Observational Study of Vision Improvement in Late Stage Dry AMD Patients

February 22, 2021 updated by: Optimal Acuity Corporation

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

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5R 1A9
        • Bochner Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with vision impairment due to late stage dry age-related macular degeneration.

Description

Inclusion Criteria:

  1. - Male or female
  2. - Any race
  3. - Patient is at least 50 years old
  4. - Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
  5. - Treated eyes were pseudophakic at the time of treatment.
  6. - 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).
  7. - Patient CDVA records are available at baseline and at 12 month post-treatment.

Exclusion Criteria:

  1. - Corneal disease or disorder in either eye.
  2. - Increased intraocular pressure (above 20 mm 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CDVA
Time Frame: 12 months
Best spectacle-corrected distance visual acuity (CDVA)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CNVA
Time Frame: 12 months
Best spectacle-corrected near visual acuity (CNVA)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Michael Berry, PhD, Optimal Acuity Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2020

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Retro1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Age-related Macular Degeneration

Clinical Trials on Corneal treatment by a low vision aid device

3
Subscribe