Primary Open Angle Glaucoma Clinical Trial
Official title:
Comparison of Porcine Submucosal Tissue Patch Graft (KeraSys) Versus Processed Pericardium Patch Graft (Tutoplast) in Glaucoma Drainage Implant Surgery Using a Molteno 3 Shunt
Verified date | November 2016 |
Source | Wills Eye |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The investigators hypothesize that KeraSys is a safe as Tutoplast to cover the tube of the Molteno 3 glaucoma drainage device during surgery
Status | Terminated |
Enrollment | 40 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: Patients with primary open-glaucoma (POAG), primary angle-closure glaucoma (PACG), pseudoexfoliation, pigmentary, traumatic, uveitic or neovascular glaucoma Exclusion Criteria: 1. Age = 18 years old. 2. Any type of glaucoma other than those listed in the inclusion criteria. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Wills Eye Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Wills Eye | IOP Ophthalmics |
United States,
Lankaranian D, Reis R, Henderer JD, Choe S, Moster MR. Comparison of single thickness and double thickness processed pericardium patch graft in glaucoma drainage device surgery: a single surgeon comparison of outcome. J Glaucoma. 2008 Jan-Feb;17(1):48-51. doi: 10.1097/IJG.0b013e318133fc49. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kerasys safety | The patch graft will be graded on appearance at each visit by slit lamp for tube erosion and conjunctival retraction. | one day, week one, 1 month, 3 month, 6 month, and 1 year | Yes |
Secondary | Long term efficacy of Kerasys and Tutoplast in Molteno 3 glaucoma shunt surgery | The thickness of the patch graft will be measured by anterior segment OCT and anterior segment photos. | 1 month, 3 month, 6 month, 1 year | Yes |
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