Observational Study of Vision Improvement in Late Stage Dry AMD Patients

NCT04349254 | Completed

• 1 other identifier: Retro1
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Age-related Macular Degeneration

Keywords

Dry AMD

Outcome Measures

Primary Outcomes (1)

• CDVA

  Best spectacle-corrected distance visual acuity (CDVA)

  12 months

Secondary Outcomes (1)

• CNVA

  12 months

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 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.

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 late stage dry age-related macular degeneration.

You may qualify if:

• \- Male or female
• \- Any race
• \- Patient is at least 50 years old
• \- Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.
• \- Treated eyes were pseudophakic at the time of treatment.
• \- 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).
• \- Patient CDVA records are available at baseline and at 12 month post-treatment.

You may not qualify if:

• \- Corneal disease or disorder in either eye.
• \- Increased intraocular pressure (above 20 mm Hg), glaucoma or history of glaucoma.
• \- 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
• Bochner Eye Institute: collaborator

Study Sites (1)

Bochner Eye Institute

Toronto, Ontario, M5R 1A9, Canada

Location

Study Officials

• Michael Berry, PhD

  Optimal Acuity Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: August 14, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)