Observational Study of Vision Improvement in Patients With Retinal Disorders

Diabetic Macular Edema Clinical Trial

Official title:

Observational Study of Vision Improvement in Patients With Retinal Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693702
• Other study ID #: Retro2
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: March 16, 2022

Study information

• Verified date: March 2022
• Source: Optimal Acuity Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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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Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Diabetic Macular Edema
• Macular Degeneration
• Macular Edema
• Retinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	Bochner Eye Institute	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Optimal Acuity Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDVA	Best spectacle-corrected distance visual acuity	12 months