N/A
N=230
5 Years Long Term Results After Standalone CyPass-Implantation
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT03114059 ↗Enrolled (actual)
230
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg — 8; 45; 22 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Glaucoma diagnostics (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dietrich-Bonhoeffer-Klinikum
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg |
8; 45; 22 | — |
| PRIMARY Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination) |
21.127; 16.553; -4.697 | — |
| PRIMARY Number of Additional Medication |
1.813; 2.014; 0.173 | — |
| PRIMARY Number of Participants With Secondary Glaucoma Procedures |
83 | — |
| SECONDARY Number of Participants With Stability of Optic Nerve |
52; 16 | — |
| SECONDARY Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness |
40; 35 | — |
| SECONDARY Number of Participants With Stability of Visual Field |
11; 49; 13 | — |
| SECONDARY Number of Participants With Stability of Stent Position |
43; 12; 13 | — |
| SECONDARY Number of Participants With Stability of Stent Tissue Interaction |
24; 32; 18 | — |
| SECONDARY Number of Participants With Intra-and Postoperative Complications |
1; 6; 5; 5; 25; 17 | — |
| SECONDARY Number of Participants With Suprachoroidal Bleb |
44; 17; 2 | — |
Summary
This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure. The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery
Eligibility Criteria
Inclusion Criteria
- patients who have undergone a standalone cypass implantation at least 3 years ago
- signed inform consent
Exclusion Criteria
- Patients with too much travel distance between study center and home
- Patients who cannot visit the studycenter due to health problems
Data sourced from ClinicalTrials.gov (NCT03114059). 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.