Clinical Trials & Studies

Investigators: Drs. Susan Cotter, Dashaini Retnasothie, Silvia Han, Angela Chen, Kristine Huang, and Reena Patel 

Why It’s Important:  Myopia or “nearsightedness” occurs when the eye grows too long. This results in distant objects being focused in front of the retina rather than on the retina. The exact cause of myopia is currently unknown; however, environmental and genetic factors seem to play a role. The amount of myopia that a child has often increases each year. Apart from the inconvenience of wearing glasses or contact lenses to be able to see clearly at distance, myopia is associated with an increased risk of eye diseases, such as retinal detachments, cataracts, macular degeneration, and glaucoma. Typically, the higher the myopia the greater the risk of developing these conditions. This is why there is a strong interest in attempting to control the progression of myopia. Currently, there are no treatments for myopia control that are approved by the Food and Drug Administration (FDA). However, recent research studies have shown that low-dose atropine eye drops and certain types of special contact lenses can slow the progression of myopia.

Description: We are one of several clinical sites participating in this FDA multi-center randomized clinical trial designed to determine the effectiveness of an eye drop (i.e., low-dose atropine) to slow the progression of myopia. Children with low to moderate levels of myopia between the ages of 3 to <17 years are eligible.

Status: ENROLLMENT OPENS DECEMBER 2017

Study Contacts: Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu. Principal Investigators - Dr. Dashaini Retnasothie: 714.463.7576; dretnasothie@ketchum.edu and Dr. Susan Cotter: 714.463.7575; scotter@ketchum.edu

Investigators:  Drs. Angela Chen, Susan Cotter, Raymond Chu, Silvia Han, Catherine Heyman, Kristine Huang, Reena Patel, Dashaini Retnasothie, Ashley Nickell, Clinton Prestwich

Why It’s Important:  Intermittent exotropia (IXT - eye turn outward) is the most common form of childhood-onset exotropia, which can cause double vision, eyestrain, sensitivity to bright lights, or cosmetically apparent misalignment (wandering outward) of the eyes. Although over-minus lens treatment is commonly used, there have been no randomized clinical trials evaluating its long-term effectiveness. Understanding the effectiveness of over-minus lens treatment for IXT has important public health implications because successful treatment may reduce the number of children undergoing surgery.

Description: This study is a multicenter randomized clinical trial designed to evaluate the long-term effectiveness of over-minus lens treatment while wearing overminus spectacles and after the overminus spectacles are discontinued. Three hundred eighty four children aged 3 to <11 years with intermittent exotropia will be randomly assigned to overminus spectacles or regular spectacles. The length of the study is 18 months.

Status:  ACTIVELY ENROLLING

Study Contact:  Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu

Funding and Additional Information:  National Institutes of Health / National Eye Institute: U10 EY11751; Registered at: ClinicalTrials.gov - Identifier: NCT02807350

Investigators:  Drs. Angela Chen, Susan Cotter, Raymond Chu, Silvia Han, Catherine Heyman, Kristine Huang, Reena Patel, Dashaini Retnasothie, Ashley Nickell, Clinton Prestwich

Why It’s Important: Amblyopia is the medical term used when the vision in one eye is reduced because the eye is not being used properly. This happens because the brain is favoring one eye over the other. It is one of the most common causes of decreased vision in children and affects approximately two or three out of every 100 children.

Randomized clinical trials and prospective observational studies have shown improvement in visual acuity with spectacle correction (when there is uncorrected refractive error) followed by treatment with part-time patching or atropine eye drops. Although these treatments are effective, not all children reach 20/20 visual acuity; in fact, residual amblyopia (20/32 or worse) remains in many treated children.

Based on the prevalence of residual amblyopia that remains with current part-time patching treatment and the challenges of compliance with patching, new treatments for amblyopia are needed, particularly those that can be visually unobtrusive and that do not overly interfere with the vision of the fellow eye.

A new treatment for amblyopia is binocular anti-suppression game therapy. This involves playing the dig rush game on an iPad while wearing red/green glasses. Recently, some studies found this treatment works very well in a number of children and adults with amblyopia. The present study is being done to compare this binocular game treatment with spectacles alone.

Description: This study is a multicenter randomized clinical trial designed to evaluate the effectiveness of 1 hour per day, 5 days per week of binocular game play on an iPad with spectacles alone in 200 children 4 to <13 years of age with amblyopia in one eye.

Status:  ACTIVELY ENROLLING

Study Contact:  Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu

Funding and Additional Information:  National Institutes of Health / National Eye Institute: U10 EY11751; Registered at: ClinicalTrials.gov - Identifier: NCT02983552

Investigators: Drs. Reena Patel and Silvia Han

Why It’s Important: Poor focusing skills (i.e., accommodative dysfunction) are commonly found in children and young adults. The frequency and severity of symptoms in these patients can vary. While there are objective tests to evaluate focusing skills, there is not a standardized way to measure symptoms associated with poor focusing skills. This study is designed to assess the validity and reliability of a questionnaire for differentiating symptomatic patients with accommodative dysfunction from those who have normal binocular vision.

Description: The study is recruiting 160 subjects between the ages of 9 to 30 years old from across the country to participate in this study. Subjects should have either accommodative dysfunction or normal binocular vision. The study visit will consist of testing vision, evaluating eye teaming and eye focusing skills and administrating questionnaires and will take approximately one hour. One week after the initial visit, subjects with accommodative dysfunction will be asked to complete a questionnaire online.

Status: ACTIVELY ENROLLING

Study Contact: Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu.

Investigators: Drs. Angela Chen, Kristine Huang

Why It’s Important: Little is known about how consistently children with various eye conditions such as amblyopia (lazy eye) and farsightedness can use their eye focusing ability, an ability called “accommodation”. The information from this study will help practitioners provide better care for children relative to their ability to effectively use their eyes.

Description: The University Eye Center at Ketchum Health is conducting a research study in children to learn more about how children with different eye conditions use their focusing system. A simple test designed for children will be used to determine how well they are able to focus their eyes. The test involves having the child watch a cartoon while measuring his or her eye focusing. Measurements will be taken three times over a span of 60-90 minutes at two separate study visits.

Status: ACTIVELY ENROLLING

Study Contacts: Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu; Dr. Angela Chen:  714.463.7569 or angelachen@ketchum.edu; Dr. Kristine Huang:  714.463.7571 or khuang@ketchum.edu.

Investigators: Drs. Susan Cotter, Carmen Barnhardt, Eric Borsting, Angela Chen, Raymond Chu, Kristine Huang, Dashaini Retnasothie

Why It’s Important: Convergence insufficiency (CI) is a common childhood eye-teaming problem where the eyes would like to drift outward when reading or doing close work. When eyes drift out, double vision can happen. To prevent double vision one must use extra effort to keep the eyes from going out. This extra effort can cause symptoms that can interfere with reading and working comfortably at near. These symptoms often include eyestrain, blurred vision, headaches, double vision, decreased comprehension and loss of place when reading or performing tasks at near. In a prior study we found that therapy improves these symptoms. In this study we are looking at whether the therapy improves reading and attention.

Children with CI have more symptoms and show worse attention when reading than children without CI. Research has shown that treatment using office-based accommodative-vergence vision therapy improves symptoms in children affected with CI. Some studies have suggested that this treatment also results in improvements in reading and attention. However, to know for sure whether this treatment has a positive effect on reading and attention, we need to study this question using a randomized clinical trial design in a large group of children.

Description: The CITT-ART is a multicenter randomized clinical trial study of 324 children ages 9 to 14 years with symptomatic convergence insufficiency (CI). The purpose of this study is to see if office-based vision therapy for convergence insufficiency improves reading ability and attention.

Status: ENROLLMENT COMPLETED; FOLLOW-UP IN PROGRESS

Study Contact: Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu.

Funding and Additional Information: National Institutes of Health / National Eye Institute: EY022595
Registered at: ClinicalTrials.gov - Identifier: NCT02207517

Investigators:  Drs. Catherine L. Heyman, and Clint Prestwich

Why It’s Important:  Providing appropriate near devices for children with visual impairment is critical for optimal educational outcomes. Currently, little is known about how children with visual impairment use their focusing system; called accommodation, when looking at near targets. This study will provide practitioners with information to better help them prescribe near devices for children with visual impairment

Description:  The University Eye Center is conducting a research study in children to learn more about how children with visual impairment use their focusing system. The study involves having the child look at a target while measuring his/her eye focusing with an autorefractor. Measurements will be taken at three different distances. Most subjects will only need one study visit, however, two separate study visits will be required if a comprehensive eye exam has not been done in the last six months.

Status:  ACTIVELY ENROLLING

Study Contacts:  Dr. Catherine Heyman:  714.992.7845 or cheyman@ketchum.edu; Dr. Clint Prestwich:  714.463.7591 or cprestwich@ketchum.edu.

Investigators: Drs. Erin Tomiyama, Angela Chen, Heidi Wagner, Surbhi Bansal, Steven Chang

Why It’s Important: Myopia or “nearsightedness" occurs when the eye grows too long and can lead to long-term visual impairments such as cataracts, glaucoma, and retinal detachments. Currently, there is one soft contact lens approved by the Food and Drug Administration (FDA) for slowing myopia progression. This study will evaluate the efficacy of this daily disposable soft contact lens in slowing myopia progression and eye growth over four years.

Description: We are one of several clinical sites participating in this randomized clinical trial designed to determine the effectiveness of an FDA-approved soft contact lens to slow the progression of myopia. Children in good health with low to moderate levels of myopia between the ages of 8 to 12 years are eligible. There are 12 study visits over 4 years. Participants will be randomly assigned to wear the myopia management contact lens (75%) or a normal contact lens (25%) for 3 years, then all participants will wear normal contact lenses for the fourth year. Disposable contact lenses will be provided at no cost and participants will be compensated for their time.

Status: Currently enrolling

Study Contacts: Study Coordinator, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu. Principal Investigator - Dr. Erin Tomiyama: 714.463.7578; etomiyama@ketchum.edu

Principal Investigators:  Drs. Barry Weissman and Justin Kwan
Co-Investigators:  Drs. Annie Chang, Elaine Chen, Britney Kitamata-Wong, Dawn Lam, Grace Liao, Eunice Myung Lee, Tim Edrington, Jerry R. Paugh and the MBKU/SCCO CL Service
Other Participating Institutions:  In slightly different form, Hadassah Academic College Department of Optometry and Massachusetts College of Pharmacy Health Sciences College of Optometry are running companion studies.

Why It’s Important: It is the general consensus of clinicians that contact lens patients should receive annual examinations to evaluate ocular and systemic health, address and manage any complications from lens wear, and renew prescription lenses (if applicable). Many patients, as well as outside interests, question the necessity of an annual exam required to renew contact lens prescriptions. In this study, we prospectively document complications encountered (in 5 areas) when subjectively asymptomatic and “successful” disposable contact lens patients present to renew their existing contact lens prescriptions.

Description: Subjects are asymptomatic disposable soft contact lens (hydrogel and silicone hydrogel) patients who present to the University Eye Center at Ketchum Health (Anaheim, CA) for routine contact lens comprehensive ophthalmic exams to renew existing contact lens prescriptions. Subjects are recruited only if they had a history of subjectively successful disposable soft lens wear for at least 1 year and no incoming ocular or contact lens-related complaints. Only subjects 15 years of age or older who did not have a history of dry eye, ocular surgery, or any eye disease other than refractive diagnoses are included.

Status: CONTINUING ENROLLMENT 

Study Contacts: Study Coordinators, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu, or Ms. Judith Wu: 714.463.7563 or jwu@ketchum.edu.

Principal Investigator:  Dr. Dawn Lam
Co-Investigators:  Drs. Elaine Chen, Justin Kwan, Caren Oquindo, Edeline Lu, Tina Zheng 

Why It’s Important: 15 to 25 year olds were found to be at two times greater risk for SCL-related complications and have a significantly higher risk for infiltrative events when compared to younger (8 to 14 years) or older contact lens wearers (26 to 33 years). The CLAY research team hypothesized that this difference might relate to contact lens wear and care behaviors, and the transition from living with a parent/guardian to independence. The CLAY Study group is interested in understanding how pediatric and young adult wearers utilize contact lenses with the long-term goal of identifying and disseminating "best practices" to promote safe and healthy SCL wear across all ages.

Description: This study will enroll contact lens wearers who present with a symptomatic red eye. Patients will be asked to complete an online questionnaire, they will be asked scripted medical history questions and their red eye will be evaluated and managed at the time of enrollment. There will be two other time points where the patients will be asked to take an online questionnaire at the 1 month and 6 month time point. Patients will receive a grading system on their level of compliance.

Status: ENROLLING DECEMBER 2017

Study Contact: Study Coordinators, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu, or Ms. Judith Wu: 714.463.7563 or jwu@ketchum.edu.

Principal Investigator: Dr. Justin Kwan
Other Participating Institutions:  The Ohio State University, The University of Waterloo, University of Jena, University of Houston

Why It’s Important: Contact lens discomfort is the leading cause of discontinuation of contact lens wear. The causative factors are varied, but the innate ocular surface (e.g., corneal sensitivity, tear film stability and composition, ocular anatomy) all likely play a role. However, there is still much to be learned concerning which factors may be most impactful to successful contact lens wear.

Description: The objective of this study is to determine what biological, non-contact lens factors contribute to contact lens comfort and successful wear time. If you are a former soft contact lens wearer and have stopped wearing them due to discomfort 6 months to 5 years ago, we would be very interested in having you as a participant. You must be between age 18 and 45.

Status: ENROLLING FALL AND WINTER 2017

Study Contact: Study Coordinators, Ms. Susan Parker: 714.463.7580 or sparker@ketchum.edu, or Ms. Judith Wu: 714.463.7563 or jwu@ketchum.edu.

Principal Investigator: Dr. Elaine Chen
Co-Investigators:  Drs. Jerry Paugh, Annie Lee, Andrew Vo

Why It’s Important: Little is known about the long-term effects of modern scleral lens wear on ocular health. While the oxygen permeability of scleral lens materials are high, numerous studies have concluded limited oxygen availability at the cornea even with thin lenses and thin tear layer in the lens reservoir.  There is no data to date that evaluates endothelial health post scleral lens wear. For these reasons, this study proposes to track the corneal endothelium in new scleral lens wearers in order to monitor the potential effects of scleral lens wear on the cornea.   

Description: A convenience, clinic-based sample of up to 40 subjects will be recruited. The sample will be comprised of subjects who have never before worn scleral lenses who are to be fit into scleral lenses. Baseline endothelial data will be collected prior to scleral lens wear using a specular microscope (Konan CellCheck XL, Konan Medical USA, Irvine, CA) and at subsequent routine visits (6 months, 1 year). 

Status: PENDING IRB APPROVAL

Study Contacts: Dr. Elaine Chen, 714.763.7590 or echen@ketchum.edu

Investigators: Drs. Susan Cotter, Angela Chen, Silvia Han, Reena Patel, Kristine Huang, Maureen Plaumann, Carlee Young, Dashaini Retnasothie

Why It’s Important: There is limited data available on adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia, the most common causes of non-paralytic adult strabismus. This study will determine how common these types of strabismus are in adult patients seen by Pediatric Eye Disease Investigator Group.

Description: This prospective adult strabismus observational study will follow adults with convergence insufficiency, divergence insufficiency or hypertropia who are being treated with prism, vision therapy, surgery, or Botox for one year. Data will be used to generate hypotheses for possible future studies, including randomized clinical trials. Adults ≥ 18 years of age with visual acuity of 20/50 or better and no prior strabismus surgery may be eligible. Data collected will include angle of deviation, diplopia severity, treatment type and treatment outcome.

Status: ACTIVELY ENROLLING

Study Contact: Study Coordinator, Ms. Sue Parker: 714.992.7817 or sparker@ketchum.edu.

Investigators: Drs. William Ridder, Pat Yoshinaga, Caren Oquindo, George Comer

Why It’s Important: The purpose of this study is to develop a vision test that detects age-related macular degeneration (AMD) at a very early stage (i.e., before acuity loss).

Description: Several visual functions will be monitored over a two-year period. This will allow for the determination of the most sensitive test for AMD and may also predict which patients develop late AMD the quickest. Thirty-five subjects will be chosen for this project. Fifteen of the subjects will be normal controls and 20 will have mild to moderate AMD.

Status: ACTIVELY ENROLLING

Study Contact: Dr. William Ridder:  714.449.7494 or wridder@ketchum.edu.

Investigators: Drs. William Ridder and Reena Patel

Why It’s Important: Amblyopia is characterized by a reduction in visual acuity, contrast sensitivity, and binocular visual functions. The two main causes of amblyopia are anisometropia and strabismus which alter the synaptic connections between neurons along the visual pathway. D-serine is an agonist of the NMDA receptor (which may play a role in neural plasticity) and may improve neurotransmission at this site. The purpose of this study is to determine if the administration of D-serine improves the visual performance in adult anisometropic amblyopes.

Description: The study enrolled 14 adult amblyopes with acuity in the amblyopic eye between 20/40 and 20/400. The study consisted of 12 weeks of amblyopia therapy followed by a 12 week follow up. Visual acuity, contrast sensitivity, sweep visual evoked potential, and blood serum serine levels were measured.

Status: ANALYZING DATA

Study Contact: Dr. William Ridder: 714.449.7494 or wridder@ketchum.edu.

Investigators: Drs. William Ridder, Patrick Yoshinaga, and George Comer

Why It’s Important: Several studies have indicated that age-related macular degeneration (AMD) affects dark adaptation, temporal contrast sensitivity, and low luminance visual acuity and contrast sensitivity in humans.  AMD’s effects on these tests will be followed longitudinally over a 2-year period.  The purpose of this project is to determine the most sensitive test for AMD and be able to predict which patients develop late AMD the quickest.

Description: The study will enroll 10 normal and 10 patients diagnosed with age-related macular degeneration. The ARMD patients must have acuity better than 20/60. The subjects will have peripheral contrast sensitivity and reading ability measured.

Status: COLLECTING DATA

Study Contact: Dr. William Ridder: 714.449.7494 or wridder@ketchum.edu

Investigators: Drs. Eric Borsting, Lawrence Stark; Dr. Christopher Chase at Western University of Health Sciences

Why It’s Important: This is a National Institute of Health funded project. This is the second phase of a long-term collaboration between Dr. Eric Borsting and Dr. Christopher Chase. The first phase of the project was funded by the National Institute of Health while Dr. Chase was a professor at Claremont McKenna College. This project studies accommodative function, the ability to focus while doing near work. Visual discomfort symptoms, such as headaches, sore eyes and blurred vision are commonly associated with prolonged reading or other near work. Researchers have long suspected accommodative dysfunction was involved but most clinical studies have failed to establish a relationship between weak accommodation and symptoms or reading impairments. Recent research, however, has found that clinical measures overestimate accommodative function and encourage the use of objective, autorefraction methods to measure and study accommodative weakness.

Description: This project will accomplish three goals. First, using autorefraction, objective and reliable procedures will be developed for measuring accommodative lag, the difference between the target location and where the eye is focused. Second, experiments will measure in real-time the impact of accommodative lag on reading fluency and visual discomfort. Third, studies will explore the role of the slow adaptive component in accommodative weakness. This work will lead to better methods for diagnosing and treating accommodative disorders.

Status: DATA ANALYSIS AND MANUSCRIPT PRODUCTION

Study Contact: Dr. Eric Borsting: 714.449.7436 or eborsting@ketchum.edu.

Investigators: Drs. Paugh, Chen (SCCO), Jamie Jester (UCI, Ophthalmology Basic Science), Eric Potma, Alba Alfonso Garcia (UCI chemistry)

Why It’s Important: Dry eye is a common condition that affects up to 10% of the population over age 40. Meibomian Gland Dysfunction (MGD) is by far the most common dry eye sub-type. However, little data are available regarding the changes in meibum, the secretion of the meibomian glands that provide the lipid layer of the tear film, relative to dry eye severity. In collaboration with UC Irvine Chemistry and Ophthalmology departments, the goal of this study was to develop a sophisticated lipid analysis system using Raman spectroscopy to determine whether the major lipid classes in meibum are altered in MGD vs. normals, and to further correlate those changes to dry eye severity. Further goals were to validate dry eye symptom questionnaires and to determine diagnostic test efficacy of common tests for dry eye such as tear osmolarity, tear breakup time, and ocular surface staining.  

Description: Adults above age 18 with and without dry eye were recruited. 150 subjects were enrolled. A comprehensive dry eye evaluation was conducted, and small amounts of meibum collected using the meibomian gland evaluator for constant pressure. The samples were analyzed by Raman spectroscopy using a machine learning approach, vertex component analysis and k-means clustering. Four major lipid classes wer identified and correlated to clinical parameters such as tear breakup time. Analysis is ongoing. 

Status: ANALYZING DATA 

Study Contact:  Dr. Jerry Paugh:  714.449.7487 or jpaugh@ketchum.edu
Funding:  Funded by an Investigator Initiated Trial (IIT) from Alcon Laboratories

Principal Investigators: Drs. Jason Ng, James Bailey

Why It’s Important: Color vision defects overwhelmingly affect males, at a rate of approximately 8% of the US male population. Color vision testing and management is frequently neglected, yet is critical to the success of individuals with regard to the education system and future fields of occupation.

The goals of the study are to better understand how test results from a given color vision test transfer to other tests, evaluate new color vision tests, and determine blur tolerances as they relate to the concordance of tests.

Description: The study is evaluating the relationship between several color vision tests as well as evaluating new color vision tests. Patients between 3 and 100 years of age, with or without known color vision problems are being recruited. Collaborations have been developed with California State University, Fullerton; University of Washington; and University of Nevada, Reno to conduct some parts of the studies.

Status: ACTIVELY ENROLLING

Study Contact: Dr. Jason Ng: 714.992.7880 or jng@ketchum.edu.

Investigators: Dr. Jerry R. Paugh, Ms. Tiffany Nguyen

Why This Study Is Important: Dry eye is a common ophthalmic condition, affecting approximately 8% of adults over age 40. There are two major types of dry eye: watery tear deficiency (called aqueous tear deficiency) and oil gland insufficiency (called Meibomian Gland Dysfunction or MGD). Of these, the oily deficiency type of dry eye is by far the most common, accounting for up to 60% of all dry eye sufferers.

Despite the high prevalence of MGD, the relative usefulness of the several clinical tests for diagnosis remain unclear.

The purpose of this investigation is to examine the diagnostic efficacy of several tests in MGD, including eyelid signs, gland secretion and gland dropout or atrophy, to determine which test or battery of tests might best identify the MGD dry eye subtype.

Description: Adults over age 18 will be enrolled who are normal (i.e. do not have dry eye) as well as those who have either the watery tear deficiency or the oily tear deficiency. Subjects will undergo an in-depth dry eye examination similar to a normal dry eye evaluation. Data will be analyzed to determine which tests are most diagnostic for MGD.

Status: ACTIVELY ENROLLING

Study Contact: Dr. Jerry Paugh: 714.449.7487 or jpaugh@ketchum.edu.

Investigators: Dr. Jerry R. Paugh, Ms. Melinda Thomas DeJesus, Drs. Corina van de Pol, Alan Sasai, William Ridder III

Why This Study Is Important: The eyelid meibomian glands provide the lipid (oily) layer of the tear film that in turn inhibits tear film evaporation and promotes tear film stability. There are several reports indicating that mechanical forces near the eye may induce meibomian gland atrophy or dropout.

The reports include contact lens wear, eyeliner tattooing, ocular prostheses and glaucoma filtering blebs. Given these associations, it is important to determine whether goggle use in young competitive swimmers may induce potentially greater gland compromise compared to recreational swimmers.

Description: Three groups of subjects will be recruited for this study, between the ages of 16 and 26 years. These will include competitive swimmers, competitive divers and normal controls with limited goggle exposure. These individuals will undergo a dry eye workup and meibography, to determine the extent of meibomian gland dropout, if any.

Status: ACTIVELY ENROLLING

Study Contact: Dr. Jerry Paugh: 714.449.7487 or jpaugh@ketchum.edu.

Investigators:  Dr. Jason Ng, Ms. Hannah Mikes

Why It’s Important:  Beyond patient education, there are few management options for patients with color vision deficiencies. Multi-notch filters are relatively new types of filters for managing color vision deficiencies. However, little objective evidence exists to evaluate them for patient use. The purpose of this investigation is to collect both objective and subjective data to better understand whether these filters can help patients with color vision issues.

Description:  Individuals between 14 – 50 years of age with inherited red-green color blindness will be enrolled to have several color vision tests conducted, both with and without filters. Participants will be able to take filters home for a trial period and return for further testing after they have real world experience with the filters.

Status:  ACTIVELY ENROLLING

Study Contact:   Dr. Jason Ng:  714.992.7880 or jng@ketchum.edu

Investigators:  Dr. Jerry R. Paugh, Ms. Mariam Alkawally

Why It’s Important:  There is almost no evidence in for potential adverse effects of eyeliner applied to the eyelid margin (i.e., on top of the meibomian gland orifices) on tear film function or meibomian gland health. Presumably if major issues were encountered by eyeliner users there would be more reports of discomfort and ocular surface compromise. This study will recruit minimal eyeliner users, and maximal eyeliner users and compare their symptoms, tear film and meibomian gland characteristics.

Description:  Subjects 18 -40 years of age will be recruited. Three groups are sought:  1) minimal makeup users, 2) makeup users but without marginal eyeliner use, and 3) makeup users with marginal eyeliner use. All subjects will undergo a comprehensive dry eye evaluation, including symptom questionnaires, tear stability testing, staining evaluation, meibomian gland secretion grading, and Schirmer test. Imaging of the meibomian glands will be effected using  the LipiView II device, and gland dropout assessed using meiboscore and percent gland area remaining. The makeup/eyeliner group will be deprived for two weeks to determine whether their key tear film characteristics change/improve.

Status:  PROPOSAL WRITING STAGE

Study Contact:  Dr. Jerry Paugh:  714.449.7487 or jpaugh@ketchum.edu

Principal Investigator:  Dr. Justin Kwan
Co-Investigator: Tiffany Yanase, SCCO 2018

Why It’s Important:  Over the last several decades, myopia (nearsightedness) has reached epidemic proportions internationally – about 50% of all young adults in the U.S. and Europe and 90% in East Asia, and at greater levels of myopia. Patients with myopia have a higher risk of eye disease in their lifetime, one of the more devastating and not too uncommon being myopic maculopathy. The goal is to discover new knowledge that will further promote efforts in slowing myopia and detect the risk of future disease as early as possible.

Description:  The objective of this study is to look at visual function in patients with nearsightedness to see if the ability to see dim lights is correlated to the degree of myopia. If you wear soft contact lenses for nearsightedness and are between the age of 18 and 59 years old, we would be very interested in having you as a participant. There will be two visits, one to two weeks apart that will be 20 to 40 minutes each.

Status:  ENROLLING FALL and WINTER 2017

Study Contacts:  Dr. Justin Kwan, jkwan@ketchum.edu, or Ms. Judith Wu: 714.463.7563 or jwu@ketchum.edu.

Investigators:  Drs. Jason Ng, Ms. Sophia Liem

Why It’s Important: Color vision testing via the Farnsworth D15 test is common practice in clinics and especially for occupational testing. For some patients the D15 test presents a barrier to career entry and as a result some patients may be motivated to subvert the test through practice. No evidence exists that such methods would actually allow individuals to pass the test though.

Description:  The study has enrolled participants with both normal and abnormal color vision. Participants had a comprehensive color vision evaluation and then were able to take the D15 test home and practice as much as desired. They then returned and were retested to see how much, if any, improvement on the test was possible.

Status:  SUBMITTING FOR PUBLICATION

Study Contact:  Dr. Jason Ng:  714.992.7880 or jng@ketchum.edu.

Investigators:  Dr. Jason Ng, Ms. Alice Wong

Why It’s Important: Vision screenings commonly report visual acuity by the lowest line read. However, the criterion to determine the best line acuity has not been researched. Is reading 3 or more letters out of 5 on a line an accurate representation of true clinical visual acuity? Or is reading all 5 letters on a line more accurate? Understanding the best criterion to use will make line visual acuities more accurate and possibly improve appropriate referral rates from vision screenings.

Description:  The study has enrolled subjects between 18 and 35 years of age. Participants need to read 8 visual acuity charts, sometimes with lenses that make the charts intentionally blurry. This was a double-masked, prospective study that will determine the best criterion to use when measuring visual acuities by best (i.e. lowest) line read.

Status:  DATA ANALYSIS

Study Contact:  Dr. Jason Ng:  714.992.7880 or jng@ketchum.edu.

Investigators:  Dr. Lawrence Stark, Mr. Scot Class

Why It’s Important:  Although visual acuity by standard letter chart is a widely used test of visual performance, its repeatability is not optimal. If repeatability could be improved then it would be possible to detect earlier genuine reductions in vision, and to detect earlier the genuine improvements due to therapies for vision. In this study, the simple approach of averaging two visual acuity readings is investigated to find if it could improve the repeatability of visual acuity. In addition, it is known that some letters are more difficult to see correctly than others. We investigate the use of a novel chart that contains a consistent set of letters on each line, to determine if it can improve measurement repeatability.

Description:  Visual acuity will be measured in 130 young individuals under standard conditions during one session.

Status: RECRUITING

Study Contact:  Dr. Lawrence Stark: 714.449.7427; lstark@ketchum.edu

Investigators:   Dr. Corina van de Pol, Van Vu

Why It’s Important:  An Accommodating Contact Lens (ACL) is in development by a start-up company, OneFocus Vision, Inc. (Florida).  The ACL has a dynamic shape changing mechanism to create accommodation for near, intermediate and distance vision, depending on the patient’s vision needs. The mechanism of action of the ACL depends on the interaction of the lower lid and the lens in various positions of gaze, from primary gaze to down gaze. Although there have been studies looking at the relationship of lid position and pupil position in various gaze angles, there have not been many studies looking at the additional interaction of the eyelids on contact lens position and how this might affect the mechanism of action of the ACL.  The aim of this study was to assess the interrelationship of pupil, lens and lid positions through a full range of gaze positions from primary gaze to down gaze.

Description:  The study was completed at Vance Thompson Vision, Sioux Falls, SD and was sponsored by OneFocus Vision, Inc. (Florida).  In this study, 15 normal presbyopic-age subjects were fit with a monofocal soft contact lens (non-ACL lens), which was pre-marked with surgical ink to indicate lens center and lens orientation.  Images were taken using a digital camera system set at a fixed distance from the eye through an arc of 4 angles from primary gaze to 250 down gaze.  The study found that the upper lid moves downward during down gaze and drives the contact lens downward and the lower lid moves upward relative to the lens center.  Due to the downward movement of the lens, the lower lid is closer to the lens center than the pupil center in complete down gaze.  These data are being used to support development of the ACL parameters.

Status: COMPLETE

Study Contact:  Dr. Corina van de Pol: 714.449.7479; cvandepol@ketchum.edu

Investigators: Dr. Lawrence Stark; Ms. Shelley Tasaka; Ms. Ashley Luke

Why This Study Is Important: This study is about how to communicate written course objectives effectively within an optometry course. It will focus on the use of behavioral objectives to inform students about what they should learn. These investigations are designed to improve local teaching practice by enhancing knowledge of how students use and understand objectives, and by determining whether objectives assist students to discover what they should learn. This study will also be of value to a wide audience of educators by contributing knowledge of how students use objectives, and how they interpret cognitive verbs used in behavioral objectives.

Description: This action-research project, funded by the Association of Schools and Colleges in Optometry and Vistakon’s Vision Care Institute will involve formal reviews of the course handbook and student exercises, followed by a class survey, two experiments and a student discussion group.

Status: DATA COLLECTION COMPLETED; ANALYZING DATA

Study Contact: Dr. Lawrence Stark: 714.449.7427 or lstark@ketchum.edu.

Investigators: Dr. Lawrence Stark, Angela Lin

Why This Study Is Important: This study’s focus is to determine whether student learning outcomes, in the form of test results on specific behavioral objectives, can be used to inform course evaluation. Importantly, the study will use a pre–post design, over two years, to determine whether course revisions can improve learning. The results will benefit educators by providing a useful tool to appraise the outcomes of instruction, to make student learning a focus of course revision, to provide new data for teaching effectiveness and departmental program review, and to improve future student learning.

Description:  This action-research project, funded by the American Optometric Foundation and Johnson & Johnson’s Vision Care Institute will involve collation of student test results, refinement of collation methodology, a student survey and discussion group, formal course reviews and a post-intervention analysis.

Status: DATA COLLECTION CONTINUES AND ENROLLMENT REMAINS OPEN

Study Contact:  Dr. Lawrence Stark: 714.449.7427 or lstark@ketchum.edu.

Investigators: Dr. Lawrence Stark, Mr. Scot Class

Why This Study Is Important: Although visual acuity by standard letter chart is a widely used test of visual performance, its repeatability is not optimal. If repeatability could be improved then it would be possible to detect earlier genuine reductions in vision, and to detect earlier the genuine improvements due to therapies for vision. In this study, the simple approach of avering two visual acuity readings is investigated to find it it could improve the repeatability of visual acuity. In addition, it is known that some letters are more difficult to see correctly than others. We investigate the use of a novel chart that contains a consistent set of letters on each line, to determine if it can improve measurement repeatability.

Description: Visual acuity will be measured in 130 young individuals under standard conditions during one session.

Status: ACTIVELY RECRUITING

Study Contact: Dr. Lawrence Stark: 714.449.7427 or lstark@ketchum.edu.

Principal Investigator: Dr. Jason Ng
Co-Investigator: Dr. Melissa Vydelingum Contreras

Why This Study Is Important: Diabetes has become an epidemic in the United States. About 8% of the US population has diabetes (~26 million; of these ~1/3 are undiagnosed), and another 80 million pre-diabetic. Diabetes is the leading cause of new cases of blindness among adults aged 20-74 years, due to the fact that of those with diabetes, roughly 30% have some form of diabetic retinopathy (e.g., retinal changes such as hemorrhages).

The goals of the study are to further investigate markers of retinal health that can be used to identify patients at high-risk for developing further diabetic eye disease or used as markers to monitor patient health during the evaluation of new treatments for diabetic retinopathy.

Description: The study is primarily evaluating the association between retinal nerve function and retinal lesions in diabetic retinopathy. Patients with or without diabetes, between 20 and 70 years of age, will be enrolled and various vision functions are measured (e.g., visual acuity, electroretinograms, macular pigment density) in addition to taking retinal photographs.

Status: DATA ANALYSIS

Study Contacts: Dr. Jason Ng:  714.992.7880 or jng@ketchum.edu.