Observational Study of Vision Improvement in Patients With Retinal Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Optimal Acuity Corporation
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- CDVA
Study Overview
Brief Summary
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders who received corneal treatments by a low vision aid device.
Detailed Description
The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female or male
- •Patient is at least 50 years old
- •Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
- •Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
- •Patient had moderate to severe baseline vision impairment with CDVA of 20/63 or worse (decimal = 0.317 or less; logMAR greater than or equal to 0.50) in the treated eye(s)
- •Patient CDVA records are available at baseline and at 1m or longer post-Tx times
Exclusion Criteria
- •1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm Hg), glaucoma or history of glaucoma 3 - Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable for retrospective observational study
Outcomes
Primary Outcomes
CDVA
Time Frame: 12 months
Best spectacle-corrected distance visual acuity
Secondary Outcomes
No secondary outcomes reported