Observational Study of Vision Improvement in Patients With Retinal Disorders

• Sponsor: Optimal Acuity Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04693702
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration; Diabetic Macular Edema	Device: Corneal treatment 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 54 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Observational Study of Vision Improvement in Patients With Retinal Disorders
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Mar 16, 2022
• Actual Study Completion Date: Mar 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Age-related Macular Degeneration	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 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	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 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.

Outcome Measures

Primary Outcome Measures

1. CDVA [12 months]

   Best spectacle-corrected distance visual acuity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bochner Eye Institute	Toronto	Ontario	Canada	M5R 1A9

Sponsors and Collaborators

• Optimal Acuity Corporation

Investigators

• Principal Investigator: Michael J Berry, PhD, Optimal Acuity Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Optimal Acuity Corporation
• ClinicalTrials.gov Identifier: NCT04693702
• Other Study ID Numbers: Retro2
• First Posted: Jan 5, 2021
• Last Update Posted: Apr 20, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Optimal Acuity Corporation: Age-related macular degeneration; Diabetic macular edema
• Additional relevant MeSH terms: Macular Degeneration; Macular Edema; Retinal Diseases

Study Results

No Results Posted as of Apr 20, 2022