Observational Study of Vision Improvement in Patients With Retinal Disorders

NCT ID: NCT04693702

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-03-16

Brief Summary

The purpose of this study is to assess the vision improvement achieved by patients with retinal disorders 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 retinal disorders, including age-related macular degeneration and diabetic macular edema, who received corneal treatments by a low vision aid device. Patient records will be analyzed to determine measures of vision improvement including best spectacle-corrected distance visual acuity (CDVA). Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Conditions

Age-related Macular Degeneration; Diabetic Macular Edema

Study Design

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

Study Groups

Age-related Macular Degeneration

Corneal treatment by a low vision aid device

Intervention Type: DEVICE

Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.

Diabetic Macular Edema

Corneal treatment by a low vision aid device

Intervention Type: DEVICE

Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.

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 modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. - Female or male

2. - Any race

3. - Patient is at least 50 years old

4. - Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes

5. - Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract

6. - Patient had moderate to severe baseline vision impairment with 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 1m or longer post-Tx times

Exclusion Criteria

1 - Corneal disease or disorder in either eye 2 - Increased intraocular pressure (above 20mm 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

Optimal Acuity Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Berry, PhD

Role: PRINCIPAL_INVESTIGATOR

Optimal Acuity Corporation

Locations

Bochner Eye Institute

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Retro2

Identifier Type: -

Identifier Source: org_study_id