Observational Study of Vision Improvement in Late Stage Dry AMD Patients

NCT ID: NCT04349254

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2020-12-31

Brief Summary

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.

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.

Conditions

Dry Age-related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bochner Eye Institute

UNKNOWN

Sponsor Role: collaborator

Optimal Acuity Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Berry, PhD

Role: PRINCIPAL_INVESTIGATOR

Optimal Acuity Corporation

Locations

Bochner Eye Institute

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Retro1

Identifier Type: -

Identifier Source: org_study_id