N/A
N=142
Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT04454138 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement. — 20; 15 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- XEN-45 gelatin microstent (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Prism Eye Institute
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement. |
20; 15 | — |
| PRIMARY Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2. |
33; 22 | — |
| PRIMARY Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3. |
28; 18 | — |
| PRIMARY Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4. |
41; 26 | — |
| PRIMARY Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5. |
31; 19 | — |
| PRIMARY Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6. |
47; 28 | — |
| SECONDARY Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. |
35; 48 | — |
| SECONDARY Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement. |
32; 40 | — |
Summary
The Xen-45 gelatin microstent is a novel, bleb-forming microinvasive glaucoma surgery (MIGS). Despite demonstrating similar efficacy and safety to trabeculectomy (traditional surgery), the Xen-45 gelatin microstent continues to suffer from occasional surgical failure due to fibrosis of the filtering bleb, and obstruction of the stent. During surgery, placement in a surgery known as supra-tenon's space is believed to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency. Despite the theoretical merits, long-term data of outcomes after targeted supra-tenon's placement is needed to fully assess its potential in improving Xen-45 microstent outcomes.
Eligibility Criteria
Inclusion Criteria
- Patients aged 30-90 with primary or pigmentary/pseudoexfolliative open angle, primary closed angle, or combined mechanism glaucoma with IOP of 18-40 mmHg on maximum tolerated medical therapy who received a gelatin stent with MMC at Prism Eye Institute from June 2012 to August 2019.
Exclusion Criteria
- Other forms of glaucoma
- Prior incisional glaucoma surgery
- CPC
- Prior corneal graft (PKP, DALK, DSAEK, DMEK).
Data sourced from ClinicalTrials.gov (NCT04454138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.