To measure surgical success of open vs closed conjunctiva with Xen implantation.
- Study Type: Observational
- Study Design
- Time Perspective: Retrospective
- Study Primary Completion Date: August 2020
This retrospective, single-arm multicenter study included >100 eyes (>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C.
Success rates will be determined based on need for re-intervention and intraocular pressure control.
- Device: Xen Gel Stent
- Ab-interno or Ab-Externa Xen with closed or open conjunctiva.
Clinical Trial Outcome Measures
- re-intervention rate
- Time Frame: 3 months
- This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation
- Change in intraocular pressure
- Time Frame: 1 day, 1 week, 1 month and 3 months
- will be assessed as a % change in intraocular pressure
Participating in This Clinical Trial
- Require surgery for uncontrolled glaucoma
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Johns Hopkins University
- New York University
- Provider of Information About this Clinical Study
Panarelli JF, Yan DB, Francis B, Craven ER. XEN Gel Stent Open Conjunctiva Technique: A Practical Approach Paper. Adv Ther. 2020 May;37(5):2538-2549. doi: 10.1007/s12325-020-01278-1. Epub 2020 Mar 21.
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