← Back to Search

Device

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

N/A
Waitlist Available
Led By Oliver D Schein, MD
Research Sponsored by VisionCare, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
65 years of age or older
Retinal findings of geographic atrophy or disciform scar with foveal involvement
Must not have
Untreated retinal tears
History of retinal detachment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after implantation
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the safety of a new eye surgery by measuring the percentage of patients who experience persistent vision-impairing corneal edema. If the percentage is low, the null hypothesis will be rejected.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include persistent vision-impairing corneal edema, which is a type of swelling in the front part of the eye that can lead to lasting loss of visual acuity more than two lines worse than before surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 65 years old or older.
Select...
I have severe eye damage involving the center of my vision.
Select...
I have a cataract that affects my vision significantly.
Select...
My other eye has good side vision.
Select...
I have severe vision loss due to advanced age-related macular degeneration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have untreated tears in my retina.
Select...
I have had a detached retina in the past.
Select...
I have a cornea disorder like guttate.
Select...
I have inflammation in my eye.
Select...
My eye's lens has a condition causing instability or pseudoexfoliation.
Select...
I have diabetic retinopathy.
Select...
I have been diagnosed with corneal guttate.
Select...
I have had high eye pressure that responds to steroids, uncontrolled glaucoma, or very high eye pressure despite medication.
Select...
I have Stargardt's disease.
Select...
I can understand and agree to medical documents and follow training.
Select...
I often rub my eyes due to an eye condition.
Select...
I have a tumor inside my eye.
Select...
I have been diagnosed with retinitis pigmentosa.
Select...
I have a disease affecting the blood vessels in my eyes.
Select...
I have a condition affecting my optic nerve.
Select...
I am younger than the required age and my endothelial cell density is too low.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years after implantation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Long term safety study of implantable miniature telescope

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Implantable Miniature TelescopeExperimental Treatment1 Intervention
Post approval study

Find a Location

Who is running the clinical trial?

VisionCare, Inc.Lead Sponsor
9 Previous Clinical Trials
437 Total Patients Enrolled
Oliver D Schein, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Implantable Miniature Telescope (Device) Clinical Trial Eligibility Overview. Trial Name: NCT01757132 — N/A
Age-Related Macular Degeneration Research Study Groups: Implantable Miniature Telescope
Age-Related Macular Degeneration Clinical Trial 2023: Implantable Miniature Telescope Highlights & Side Effects. Trial Name: NCT01757132 — N/A
Implantable Miniature Telescope (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01757132 — N/A
~50 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top