TerminatedNot Applicable

Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube

Stopped: kerasys had more erosions than tutoplast

United States40 participantsStarted 2010-08

Plain-language summary

The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Age ≤ 18 years old.
. Any type of glaucoma other than those listed in the inclusion criteria.
. Less than 3 months of other ocular surgery.
. Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
. Patients with connective tissue disorder.
. Patients with congenital or developmental glaucoma.
. Patients with severe dry eye syndrome.
. Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kerasys safety

Timeframe: one day, week one, 1 month, 3 month, 6 month, and 1 year

Trial details

NCT IDNCT01301378

SponsorWills Eye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials