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NCT Number: NCT04875234

Vision Improvement for Legally Blind Dry AMD 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clear-K Low Vision Aid Treatment

Device

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.

Primary outcomes

  1. Best spectacle-corrected distance visual acuity (BCDVA)

    Time frame: 12 months post-treatment

    BCDVA measured using ETDRS eye charts

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Berry, PhD

CONTACT

[email protected]

831-869-1384

Sponsors and collaborators

Lead sponsor

Optimal Acuity Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 6, 2021
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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