Treatment Outcomes of Mitomycin C-Augmented Trabeculectomy, Sub-Tenon Injection versus Soaked Sponges, after 3 Years of Follow-up: A Randomized Clinical Trial.
Ophthalmol Glaucoma
; 1(1): 66-74, 2018.
Article
en En
| MEDLINE
| ID: mdl-32672635
ABSTRACT
PURPOSE:
To report the 3-year outcome of trabeculectomy with mitomycin C (MMC)-soaked sponges versus intra-Tenon injection of MMC in eyes with uncontrolled primary open-angle glaucoma.DESIGN:
Randomized clinical trial.PARTICIPANTS:
Eighty-two consecutive patients with uncontrolled primary open-angle glaucoma.METHODS:
Participants were randomized either to intra-Tenon injection of 0.1 ml of 0.01% MMC (TI group) or 0.02% subconjunctival application of MMC-soaked sponges (TS group). Patients were followed up for 3 years after surgery. The data for 73 eyes were included in the final analysis. MAIN OUTCOMEMEASURES:
The primary outcome measure was the surgical success, defined as intraocular pressure (IOP) more than 5 mmHg and <21 mmHg, and IOP reduction of 20% or more from baseline, no reoperation for glaucoma, and no loss of light perception vision. Secondary outcome measures were IOP, glaucoma medications, best-corrected visual acuity (VA), bleb morphologic features according to the Indiana Bleb Appearance Grading Scale, complications, and endothelial cell count changes.RESULTS:
The cumulative probability of success at 3-year follow-up was 72.2% in the TI group and 65.1% in the TS group (P = 0.30). Uncontrolled IOP was the most common reason for failure. The mean preoperative IOP was 22.4±4.6 mmHg with an average of 3.1±1.0 medications. At 3 years, final IOP was 15.3±3.7 mmHg in the TI group and 16.4±3.5 mmHg in the TS group (P = 0.55). Mean glaucoma number of medications was 0.9±1.1 and 1.1±1.1 in the TI and TS groups, respectively (P = 0.54). Blebs tended to be more diffuse (P = 0.032), less vascularized (P = 0.013), and more shallow (P = 0.012) after intra-Tenon injection. Visual outcomes and endothelial cell changes were similar in both groups (P = 0.47 and P = 0.94, respectively).CONCLUSIONS:
Although the success rate and IOP reduction were comparable with both techniques, bleb morphologic parameters were more favorable after intra-Tenon injection of 0.1 ml of 0.01% MMC.
Texto completo:
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Base de datos:
MEDLINE
Asunto principal:
Trabeculectomía
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Tapones Quirúrgicos de Gaza
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Glaucoma de Ángulo Abierto
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Mitomicina
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Presión Intraocular
Tipo de estudio:
Clinical_trials
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Observational_studies
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Prognostic_studies
Idioma:
En
Revista:
Ophthalmol Glaucoma
Año:
2018
Tipo del documento:
Article