Vision Improvement for Legally Blind Dry AMD Patients

March 21, 2023 updated by: Optimal Acuity Corporation

Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

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

Study Contact

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with dry age-related macular degeneration an legal blindness in one or both eyes

Description

IInclusion Criteria:

  • Male or Female
  • Any race
  • Patient is at least 50 years old.
  • Patient must have dry AMD in the study eye.
  • Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.
  • Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).
  • Patient is not a contact lens wearer.
  • Patient is willing and able to comply with all examinations.
  • Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

  • Visually significant cataract in the study eye
  • Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
  • Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
  • Previous corneal surgery in the study eye
  • Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Legally Blind Dry AMD Patients
Legally Blind Dry AMD Patients with either unilateral or bilateral blindness
Device: Clear-K Low Vision Aid Treatment
A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best spectacle-corrected distance visual acuity (BCDVA)
Time Frame: 12 months post-treatment
BCDVA measured using ETDRS eye charts
12 months post-treatment

Collaborators and Investigators

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

Sponsor

Optimal Acuity Corporation

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 (Anticipated)

January 1, 2024

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retro3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

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.

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