Research at the Southern California College of Optometry

Jerry R. Paugh, O.D., Ph.D. – Director of Research
Morris S. Berman, O.D., M.S. – Vice President and Dean of Academic Affairs

The mission of the Southern California College of Optometry is to provide the highest quality optometric education through excellence in teaching, patient care and research. Within this context, the College has made important strides in recent years to foster faculty research.

The majority of funded research at SCCO is clinical in nature and is conducted in the Eye Care Clinic by more than 20 clinical faculty members and 4 full-time personnel of the Center for Vision Research. The Center for Vision Research represents the clinical research support infrastructure of the College and is staffed by the Director of Research, a full-time research optometrist, and two full-time study coordinators. The College also supports a dedicated Institutional Review Board that meets bi-monthly to review each research project, an infrastructure component that further facilitates student and faculty projects on campus.

Funded projects at SCCO represent a broad spectrum of disciplines within vision research, and are aligned with the traditional strengths of the College. These are in the areas of refractive error development, pediatric optometry and binocular vision, cornea and contact lenses, and ocular disease. Detailed below are a few of the major initiatives being carried out at SCCO in these areas.

Selected Research Projects at the Southern California College of Optometry:

Refractive Error Development:

Collaborative Longitudinal Evaluation of Ethnicity and Refractive Error
(CLEERE):
Is myopia progression an environmental occurrence or are there genetic predispositions across different ethnicities? Few studies simultaneously compare different races, and it is problematic at best to compare across races in different geographic areas, different cultures, and in samples with different socio-economic and educational bases.

The CLEERE study is a multi-center observational investigation of ocular growth and refractive error development in school children ages 6 to 14. The purposes of CLEERE are to 1) compare and contrast normal ocular growth, ocular component development and refractive error development in African-American, Asian, Hispanic and American-Indian schoolchildren with that of Caucasian children from the Orinda Longitudinal Study of Myopia, 2) develop the ability to predict juvenile-onset myopia before it is clinically evident and 3) conduct DNA-based studies on myopic children and their families. Measurement methods include cycloplegic autorefraction, autokeratometry, videophakometry, and A-scan ultrasonography. The SCCO team, which is headed by Dr. Julie Yu and includes Drs. Susan Cotter, Soonsi Kwon, John Lee, Raymond Maeda and Raymond Chu, is responsible for gathering data on primarily Asian children and examines approximately 500 children yearly in the Irvine school district.

Multi-Center Studies of 2% Pirenzepine Ophthalmic Gel in Children with Myopia:
Pirenzepine is a relatively selective anti-muscarinic agent that may slow the progression of myopia in children. At SCCO Drs. Susan Cotter, Soonsi Kwon and Ray Chu are investigators for three FDA drug trials (PIR-205, PIR 205A, and the Open Label Safety Study) examining myopia progression relative to pirenzepine administration. The main goals are to determine: 1) the ability of 2% pirenzepine ophthalmic gel to slow the progression of myopia in 8-12 year old healthy children and 2) the safety profile of this medication. The Open Label Safety Study will be the third year of treatment with 2% pirenzepine for many of the children. In the spring of 2003, the SCCO investigators will participate in a “dose-response” study of pirenzepine to compare different strengths of the medication. In a recent press release, Novartis Ophthalmics announced that in the Phase II clinical trials pirenzepine has been shown to reduce myopia progression by at least 50% in the first 12 months of treatment.

Pediatric Optometry and Binocular Vision:

Convergence Insufficiency Treatment Trial (CITT) Pilot:
Convergence Insufficiency (CI) affects approximately 5% of children and adults in the US and can significantly affect school performance and quality of life. Currently, there is no consensus as to the most effective form of treatment for CI.

The CITT Pilot Study was an NEI-funded planning grant in which three SCCO faculty members, Drs. Susan Cotter, Michael Rouse, and Eric Borsting served on the CITT Planning Committee, and Drs. Carmen Barnhardt, Raymond Chu, Soonsi Kwon and John Lee assisted with the pilot study. The CITT Pilot study was a multi-center, randomized, controlled and masked study of CI to compare the success rate of pencil push-up treatment, vision therapy/orthoptics, and placebo vision therapy/orthoptics for the treatment of 9 to 30-year-old patients with symptomatic convergence insufficiency. Preliminary analysis is presently underway.

Amblyopia Treatment Studies (ATS1, ATS2A/B, ATS2C, ATS3, ATS4):
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Patching therapy has been the mainstay of amblyopia treatment despite the lack of meaningful data demonstrating its superiority compared with other modes of treatment. Opinions vary on the number of hours of patching that should be prescribed and compliance is often a problem. Pharmacological penalization with atropine has been reported to result in better compliance. There are many questions regarding different approaches to treatment of amblyopia, which form the basis for the series of ATS studies being carried out at SCCO in conjunction with the Pediatric Eye Disease Investigator Group (PEDIG). PEDIG is comprised of pediatric optometrists and ophthalmologists at more than 50 clinical sites throughout North America.

The Amblyopia Treatment Studies (ATS) are funded by the NEI and coordinated by the Jaeb Center for Health Research in Tampa, Florida. The overall goal of the ATS studies is to determine the most effective treatments for amblyopia in patients of various ages.

SCCO Faculty involved with the ATS studies include Principal Investigator Dr. Susan Cotter, and Investigators Drs. Carmen Barnhardt, Susan Shin and Ray Chu. Progress to date for ATS 1 is as follows.

ATS 1: This multi-center randomized trial was designed to determine whether the success rate with atropine treatment of moderate amblyopia due to strabismus or anisometropia in patients less than 7 years old is equivalent to the success rate with occlusion (patching) therapy. Six-month outcome results were recently published in Archives of Ophthalmology. The study found that atropine and patching produced improvements of similar magnitude, and that both treatments are appropriate modalities for the initial treatment of moderate amblyopia in children 3 to 7 years of age.


Vision Screening & Vision Therapy Project:
Funded by a private foundation, Children in Focus, and headed by faculty member Dr. Lynn Marran, this project is screening 1000 sixth graders in the Fullerton elementary school system for refractive error and for oculomotor deficits in accommodation, vergence, and ocular motility. Incidence of oculomotor disorders and any correlation with SAT-9 scores will be determined. Approximately 60 children whose oculomotor profiles qualify them for study inclusion will be enrolled in one of 3 treatment groups, optical correction with prism and/or plus lenses; 10 weeks of vision therapy or delayed treatment and randomization into optical or vision therapy treatment. Outcome measures will include objective oculomotor measures of accommodation, vergence, and ocular motility; reading comprehension tests; a subjective clinical oculomotor assessment; and a symptom survey.

Preliminary analysis suggests a 20% problem rate for near vision skills that are needed for reading. The treatment phase of the research should provide valuable data as to which therapy might be most effective. Overall this investigation demonstrates SCCO’s commitment to the community and to the furtherance of understanding in the important area of vision as it relates to learning and school performance.

Cornea and Contact Lenses:

Collaborative Longitudinal Evaluation of Keratoconus (CLEK):

Keratoconus is a visually disabling thinning disorder of the central cornea that may result in irregular astigmatism, progressive corneal distortion, and corneal scarring. Although much is known about keratoconus, many scientific questions persist relative to this debilitating condition which provide the basis for the CLEK studies.

The CLEK investigation is a multi-center observational study supported by the NEI. Dr. Tim Edrington serves on the CLEK Executive Committee, Dr Julie Yu is the Principal Investigator at SCCO and Dr. Raymond Chu is a co-investigator. Eighty keratoconic subjects (from a clinic population of more than 450 keratoconics) are being followed over nine years at SCCO. The purposes of the study are to 1) prospectively characterize changes in vision, corneal curvature, corneal status (i.e., corneal scarring), and quality of life in keratoconus patients and 2) identify risk factors and protective factors that determine the severity and progression of the disease over time. Upon completion in 2004, the CLEK study will provide a clearer picture of the changes that occur in keratoconus. As is typical with these types of large investigations, standardized protocols for grading and characterizing the clinical changes in keratoconus have been developed, that may become the standard for clinicians working with this challenging condition.

Ocular Disease:

FDA Trials:

The SCCO Chronic Care Faculty are involved in several Phase III FDA trails for major ophthalmic sponsors. These trials are proprietary in nature, meaning that results and data from the investigative site may not be shared with the profession, but provide an early and insightful perspective into promising new treatments for ocular disease.

At SCCO, Principal Investigators Drs. George Comer and Judy Tong have headed up two investigations of promising fourth generation fluoroquinolone antibiotics for acute bacterial conjunctivitis. These studies are challenging since the acute condition “presents” at varying timepoints, but in both investigations SCCO was able to enroll large numbers of appropriate subjects. SCCO medical Faculty Drs. John Maher and Robert Lingua were instrumental in facilitating these efforts.

Ocular Surface Disease (OSD) Dry Eye:
Dry eye is a non-morbid condition that is nonetheless symptomatic and frustrating for those afflicted. Depending on sub-type, dry eye affects up to 10% of the population, making it one of the most common problems presenting to eyecare practices. SCCO has established a major effort in dry eye research, that involves both clinical studies and more applied investigations. The College welcomes area practitioners to refer patients for tear film workup as an ongoing effort to understand the etiology and effective treatment for dry eye. Specific investigations include:

The Effect of Increased Peri-ocular Humidity on Tear Parameters in Dry Eye:
Dr. Jerry R. Paugh has directed a series of studies involving approximately 75 subjects using traditional and non-invasive tear film evaluation methods to better characterize dry eye by sub-type and to evaluate potential treatment approaches. The non-invasive tests include tear film interferometry (i.e., the use of interference patterns to characterize the outermost lipid layer) and non-invasive breakup time (through use of a “xeroscope”). This work has demonstrated that goggle wear significantly improves lipid payer appearance and non-invasive breakup time, although tear meniscus height and tear stability do not change. The findings reinforce the notion of spectacle side shields (i.e., “moisture shields”) as an effective treatment for these types of dry eye.

Visual Effects of Artificial Tear Supplements on Contrast Sensitivity:
There are at least three major performance aspects of topical formulations used to treat dry eye. They are comfort, efficacy (e.g., residence time, or the ocular dwell time) and the impact on vision. The visual effects of tear supplements have only recently received attention by researchers and manufacturers, due mainly to the expansion of viscosity options of the available products.

In a series of studies, Dr. William Ridder has systematically evaluated the effect of different viscosity artificial tears on vision by assessing contrast sensitivity. Temporal changes in tear film structure (e.g., as from drying of the tear layer) can distort the optical wavefront as it passes through the tear layer and subsequently reduce contrast sensitivity. As expected, the higher viscosity formulations reduce contrast sensitivity (on the order of 30 to 40%) vs. the very small and transient decrease found for low-viscosity artificial tears. Moreover, the decreased contrast sensitivity was observed for up to 25 minutes, which is in good agreement with other methods of residence time determination for similar products. This research is fundamental to our understanding of ocular formulations, and can be used to good advantage to optimize more effective dry eye therapies.

Collaboration with Area Institutions:

Investigating the Visual System of Genetically Altered Mice with Electroretinograms (ERGs) and Visual Evoked Potentials (VEPs):

In a series of investigations, faculty member Dr. William Ridder, has been collaborating with medical researchers at University of California Los Angeles in measuring VEPs in genetically altered mice that have a condition resembling multiple sclerosis to determine if their visual pathways are affected. In addition, they are developing sweep VEPs measures of visual acuity in normal mice so that this method can later be used to monitor acuity in mice with various visual defects.

Multi-Ethnic Pediatric Eye Disease Study (MEPEDS):

Recognizing that various ethnic groups were under represented in prior epidemiological studies, the NIH/NEI has made a concerted effort to support studies aimed at understanding visual conditions in non-Caucasian individuals. One such study is the MEPEDS investigation headquartered at the University of Southern California’s Department of Ophthalmology, for which the NEI awarded funding of more than $11 million. Dr. Rohit Varma of USC serves as Principal Investigator (PI) with Dr. Susan Cotter of SCCO serving as co-PI. MEPEDS is an epidemiologic investigation aimed at estimating the prevalence of amblyopia, strabismus and refractive error in a population-based sample of 12,000 Caucasian, Latino, African American and Asian children aged 6 to 72 months of age. The study will also evaluate the association of selected demographic, behavioral and biologic risk factors with these ocular disorders.