Observational Study of Vision Improvement in Late Stage Dry AMD Patients

Overview

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.

Full Title of Study: “Observational Study of Vision Improvement in Late Stage Dry AMD Patients by a Low Vision Aid Device”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

  • Device: Corneal treatment by a low vision aid device
    • Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.

Clinical Trial Outcome Measures

Primary Measures

  • CDVA
    • Time Frame: 12 months
    • Best spectacle-corrected distance visual acuity (CDVA)

Secondary Measures

  • CNVA
    • Time Frame: 12 months
    • Best spectacle-corrected near visual acuity (CNVA)

Participating in This Clinical Trial

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. -

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Optimal Acuity Corporation
  • Collaborator
    • Bochner Eye Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Berry, PhD, Principal Investigator, Optimal Acuity Corporation

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