Observational Study of Vision Improvement in Patients With Retinal Disorders

NCT04693702 | Completed

• 1 other identifier: Retro2
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-related Macular Degeneration; Diabetic Macular Edema

Keywords

Age-related macular degeneration; Diabetic macular edema

Outcome Measures

Primary Outcomes (1)

• CDVA

  Best spectacle-corrected distance visual acuity

  12 months

Study Arms (2)

Age-related Macular Degeneration

Device: Corneal treatment by a low vision aid device

Diabetic Macular Edema

Device: Corneal treatment by a low vision aid device

Interventions

Corneal treatment by a low vision aid device 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.

Age-related Macular Degeneration; Diabetic Macular Edema

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with vision impairment due to retinal disorders involving central vision loss

You may qualify if:

• \- Female or male
• \- Any race
• \- Patient is at least 50 years old
• \- Patient has diagnosed retinal disorder that causes central vision loss in one or both eyes
• \- Treated eyes, at time of treatment, were pseudophakic or phakic with no significant vision loss due to cataract
• \- 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)
• \- Patient CDVA records are available at baseline and at 1m or longer post-Tx times

You may not qualify if:

• 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

Sponsors & Collaborators

• Optimal Acuity Corporation: lead

Study Sites (1)

Bochner Eye Institute

Toronto, Ontario, M5R 1A9, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Michael J Berry, PhD

  Optimal Acuity Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: October 1, 2021
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)