Phase 4
Completed N=100
Subconjunctival Versus Direct Mitomycin C in Trabeculectomy
Source: ClinicalTrials.gov NCT04352660 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds — 21; 21; 1; 3 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. This study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of IOP lowering effect, bleb appearance and complications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds |
21; 21; 1; 3; 6; 9 | — |
| SECONDARY Bleb Morphology |
1.6; 1.7; 2.2; 2.0; 1.5; 1.5 | — |
| SECONDARY Medications |
30; 32; 3; 4; 1; 1 | — |
| SECONDARY Visual Acuity |
0.11; 0.03 | — |
| SECONDARY Number of Participants With Surgical Complications |
3; 1; 2; 5 | — |
| SECONDARY Number of Participants Requiring Additional Surgery |
8; 5; 2; 1; 0; 1 | — |
| SECONDARY Postoperative Interventions |
3.3; 3.2; 2.0; 1.6 | — |
Eligibility Criteria
Inclusion Criteria
- medically uncontrolled glaucoma
- healthy and freely mobile conjunctiva in superior bulbar region
Exclusion Criteria
- previous incisional glaucoma surgery
- no light perception vision
- pregnant or nursing women
- iris neovascularization or proliferative retinopathy
- iridocorneal endothelial syndrome
- chronic or recurrent uveitis
- steroid-induced glaucoma
- pathologic myopia or refractive error less than -6.00 diopters
- unwillingness or inability to give consent
- inability to return for scheduled protocol visits
Data sourced from ClinicalTrials.gov (NCT04352660). 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. Informational only — not medical advice.