Observational Study of Vision Improvement in Patients With Retinal Disorders

Optimal Acuity Corporation1 site in 1 country54 target enrollmentOctober 1, 2021

ConditionsAge-related Macular Degeneration Diabetic Macular Edema

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Age-related Macular Degeneration
Sponsor: Optimal Acuity Corporation
Enrollment: 54
Locations: 1
Primary Endpoint: CDVA
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 1, 2021

End Date

March 16, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Optimal Acuity Corporation

Responsible Party

Sponsor

Eligibility Criteria

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