Observational Study of Vision Improvement in Patients With Retinal Disorders

Completed

• Conditions: Age-related Macular Degeneration; Diabetic Macular Edema
• Interventions: Device: Corneal treatment by a low vision aid device

• Registration Number: NCT04693702
• Lead Sponsor: Optimal Acuity Corporation

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 Timeline

• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Study Start: 2021-10-01
• Status Verified: 2022-03
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. • Female or male
2. • Any race
3. • Patient is at least 50 years old
4. • Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
5. • Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
6. • 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)
7. • 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age-related Macular Degeneration	Corneal treatment by a low vision aid device	-
Diabetic Macular Edema	Corneal treatment by a low vision aid device	-

Primary Outcome Measures

Name	Time	Method
CDVA	12 months	Best spectacle-corrected distance visual acuity

Trial Locations

Locations (1)

Bochner Eye Institute; 🇨🇦 Toronto, Ontario, Canada