Observational Study of Vision Improvement in Late Stage Dry AMD Patients

Dry Age-related Macular Degeneration Clinical Trial

Official title:

Observational Study of Vision Improvement in Late Stage Dry AMD Patients by a Low Vision Aid Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349254
• Other study ID #: Retro1
• Status: Completed
• Start date: August 14, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Optimal Acuity Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. Patient records for patients with at least 12 months follow-up will be analyzed to determine measures of vision improvement including best spectacle-corrected distance and near visual acuity. Analyses will include descriptive statistics and correlation between outcomes and baseline characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

Inclusion Criteria:

1. - Male or female

2. - Any race

3. - Patient is at least 50 years old

4. - Patient has diagnosed late stage dry age-related macular degeneration in one or both eyes.

5. - Treated eyes were pseudophakic at the time of treatment.

6. - 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).

7. - Patient CDVA records are available at baseline and at 12 month post-treatment.

Exclusion Criteria:

1. - Corneal disease or disorder in either eye.

2. - Increased intraocular pressure (above 20 mm 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

• Dry Age-related Macular Degeneration
• Macular Degeneration

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 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.

Locations

Country	Name	City	State
Canada	Bochner Eye Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Optimal Acuity Corporation	Bochner Eye Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CDVA	Best spectacle-corrected distance visual acuity (CDVA)	12 months
Secondary	CNVA	Best spectacle-corrected near visual acuity (CNVA)	12 months