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Clinical Trials/NCT04349254
NCT04349254
Completed
Not Applicable

Observational Study of Vision Improvement in Late Stage Dry AMD Patients by a Low Vision Aid Device

Optimal Acuity Corporation1 site in 1 country17 target enrollmentAugust 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dry Age-related Macular Degeneration
Sponsor
Optimal Acuity Corporation
Enrollment
17
Locations
1
Primary Endpoint
CDVA
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to assess the vision improvement achieved by patients with late stage dry age-related macular degeneration 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 late stage dry age-related macular degeneration who received corneal treatments by a low vision aid device. Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity. Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Registry
clinicaltrials.gov
Start Date
August 14, 2020
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female
  • Patient is at least 50 years old
  • Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
  • Treated eyes were pseudophakic at the time of treatment.
  • Patient had moderate to severe baseline vision impairment with best spectacle-corrected distance visual acuity (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 12 month post-treatment.

Exclusion Criteria

  • Corneal disease or disorder in either eye.
  • Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma.
  • 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 (CDVA)

Secondary Outcomes

  • CNVA(12 months)

Study Sites (1)

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