Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube
Stopped early · Not applicable
Conditions studied: Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma, Traumatic Glaucoma, Uveitic Glaucoma, Neovascular Glaucoma
In brief
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery
Key facts
- Study ID
- NCT01301378
- Run by
- Wills Eye
- People needed
- 40
- Starts
- 2010-08-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2016-11-22
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma
You may not qualify if…
- 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.
- Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
- Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
- Patients with any prior history of allergy to the active compound.
- Pregnancy or breast-feeding.
- Patients enrolled in other prospective clinical trials.
- Patients that plan to use contact lens after surgery.
Where it is running
- Wills Eye Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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