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Keep this study
Lead
Wills Eye
With
IOP Ophthalmics
This study compares patients who will undergo Molteno 3 shunt implant surgery with 1 group receiving KeraSys patch graft and the 2nd group receiving Tutoplast patch graft. The investigators will examine the efficacy and safety of KeraSys in comparison with Tutoplast and monitor the long term effectiveness for preventing tube erosion in Molteno 3 tube shunt surgery for 1 year.
Age
19–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma
3. Less than 3 months of other ocular surgery.
4. Active thyroid-related immune orbitopathy, carotid-cavernous fistula, Sturge Weber syndrome, orbital tumors or orbital congestive disease.
5. Patients with connective tissue disorder.
6. Patients with congenital or developmental glaucoma.
7. Patients with severe dry eye syndrome.
8. Patients with any surgical procedure involving revision, removal, or change of the existing glaucoma tube shunt.
9. Patients undergoing any surgical concomitant surgical procedure involving the posterior segment.
10. Patients with active scleritis, history of ocular trauma including chemical burn, chronic ocular inflammatory disease, or ocular surface disease.
11. Patients with any prior history of allergy to the active compound.
12. Pregnancy or breast-feeding.
13. Patients enrolled in other prospective clinical trials.
14. Patients that plan to use contact lens after surgery.
You may not be if
1. Age ≤ 18 years old.
Clareo Health | Patch Graft Material Safety and Effectiveness in Covering Glaucoma Drainage Device Tube
