Glaucoma | Human Optokinetic Contrast Device (HOCD) to Measure Visual Function and Identify Patients With and Without Glaucoma
Glaucoma research study
What is the primary objective of this study?
The purpose of this study is to determine if an optokinetic contrast detection device is sufficient to measure contrast sensitivity and to distinguish between patients with and without glaucoma.
Who is eligible to participate?
Inclusion Criteria: Normal controls for Study 1 1. Male or Female 2. age 18 or older 3. Corrected visual acuity 20/40 or better in both eyes. Normal Controls for Study 2 1. Male or Female 2. age 50 or older 3. IOP (intraocular pressure) 21 or less in both eyes 4. Corrected visual acuity 20/40 or better in both eyes. Subjects with glaucoma/ocular hypertension 1. Male or Female 2. Age 50 or older 3. Defined as IOP> 21 without medication on two or more clinic visits in one or both eyes 4. Corrected visual acuity 20/40 or better 5. Normal optic nerves 6. Normal automated perimetry in both eyes Subjects who are glaucoma/glaucoma suspects 1. Male or Female 2. Age 50 or over 3. Increased optic nerve cupping in one or both eyes regardless of IOP 4. Corrected visual acuity 20/40 or better 5. Normal automated perimetry in both eyes Subjects with early to moderate glaucoma 1. Male or female 2. Age 50 or over 3. Increased optic nerve cupping regardless of IOP in one or both eyes 4. Corrected visual acuity 20/40 or better in both eyes 5. Early to moderate perimetric changes defined as a mean deviation (MD) no less than -7.5 and a pattern standard deviation (PSD) no greater than +7.5 in the worse eye. Subjects with moderate to advanced glaucoma 1. Male of Female 2. Age 50 or older 3. Increased optic nerve cupping regardless of IOP in one or both eyes 4. Grossly abnormal automated perimetry (MD less than -7.5 or PSD greater than +7.5 in the worse eye) 5. Best-corrected visual acuity of 20/40 or better in both eyes Exclusion Criteria: - Normal Controls (both studies): 1. glaucoma or glaucoma suspicion in either eye 2. IOP > 21 in either eye 3. History of use of IOP-reducing drops in either eye except temporarily following cataract extraction 4. History of any ocular surgery except cataract extraction or refractive surgery (LASIK, PRK, or equivalent) in either eye 5. Retinal disease in either eye 6. Abnormal measured automated perimetry in either eye 7. Abnormal measured contrast sensitivity in either eye
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:HOCDcomparison of HOCD results between subjects with and without glaucoma
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Normal - No glaucomaHOCD
Start Date: May 2015
Completed Date: July 2021
Primary Outcome: Estimated contrast sensitivity in log units
Secondary Outcome: Distinguish patients with and without glaucoma (statistically different log units of contrast sensitivity)
Study sponsors, principal investigator, and references
Principal Investigator: Benjamin J. Frankfort, M.D. PhD.
Lead Sponsor: Benjamin Frankfort, MD, PhD