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Not yet recruiting NCT04875234

Vision Improvement for Legally Blind Dry AMD Patients

— Observational Dry Age-related Macular Degeneration Vision Impairment and Blindness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clear-K Low Vision Aid Treatment.
Who it may be relevant to
Registry conditions: Dry Age-related Macular Degeneration, Vision Impairment and Blindness. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Best spectacle-corrected distance visual acuity (BCDVA) [Time frame: 12 months post-treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04875234 · Retro3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗