Implantable Miniature Telescope for Age-Related Macular Degeneration
(PAS-01 Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen byOliver D Schein, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VisionCare, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The objective of the PAS-01 study is to assess the safety of the intraocular as measured by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity \>2 lines from pre-surgery baseline level). The study will test the null hypothesis that the percentage of patients who experience persistent vision-impairing corneal edema is \>17% against the alternative that the percentage is \<17%. The null hypothesis will be rejected if the upper bound of the two-sided 95% confidence integral for the observed percentage is \<17%.

Eligibility Criteria

This trial is for people over 65 with severe to profound vision loss due to age-related macular degeneration, who have a cataract and can improve their sight with an external telescope. They must be able to train for the device use and not have had any eye surgery or conditions like glaucoma that could complicate results.

Inclusion Criteria

I am 65 years old or older.

I have severe eye damage involving the center of my vision.

I have a cataract that affects my vision significantly.

+4 more

Exclusion Criteria

I have untreated tears in my retina.

I have had a detached retina in the past.

Narrow angle, i.e., <Schaffer grade 2

+21 more

Participant Groups

The study evaluates the safety of an Implantable Miniature Telescope in patients with macular degeneration by checking if less than 17% develop serious corneal swelling within five years post-implantation, which would worsen their vision significantly from before the surgery.

1Treatment groups

Experimental Treatment

Group I: Implantable Miniature TelescopeExperimental Treatment1 Intervention

Post approval study