Your session is about to expire
← 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years after implantation
Awards & highlights
PAS-01 Trial 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.Check my eligibility
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.See study design
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.
PAS-01 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
PAS-01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years after implantation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years after implantation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Long term safety study of implantable miniature telescope
PAS-01 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have untreated tears in my retina.I have had a detached retina in the past.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.I have a cornea disorder like guttate.I have inflammation in my eye.My eye's lens has a condition causing instability or pseudoexfoliation.I have diabetic retinopathy.I have been diagnosed with corneal guttate.I have had high eye pressure that responds to steroids, uncontrolled glaucoma, or very high eye pressure despite medication.I have a disease affecting the blood vessels in my eyes.I have a condition affecting my optic nerve.My other eye has good side vision.I have Stargardt's disease.I have had CNV or treatment for it in the last 6 months.I can understand and agree to medical documents and follow training.I have had eye surgery before or plan to within a month of the telescope surgery.I often rub my eyes due to an eye condition.I have a tumor inside my eye.I have been diagnosed with retinitis pigmentosa.I agree to participate in training and assessments before and after surgery.I am younger than the required age and my endothelial cell density is too low.I have severe vision loss due to advanced age-related macular degeneration.
Research Study Groups:
This trial has the following groups:- Group 1: Implantable Miniature Telescope
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there presently any open opportunities to join the trial?
"According to clinicaltrials.gov, this study is not accepting patients as of now - it was initially posted on August 1st 2010 and last updated November 15th 2018. However, there are currently nine other trials actively seeking participants."
Answered by AI
What number of hospitals are currently conducting this experiment?
"16 medical centres are enrolling patients for this trial. These include Ann Arbor, New york and Eugene amongst other locations. It is advised that you choose the closest clinic to minimize travel requirements if accepted into the study."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger