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

Age range19 Years

SexALL

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

✕. 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.

Kerasys safety

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

NCT IDNCT01301378

SponsorWills Eye

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01