To investigate the safety and efficacy of Ologen (OLO) implant (Kestrel Medical Ltd, Broadstone, Dorset) for trabeculectomy revision surgery versus trabeculectomy revision with Mitomycin C 0.3mg/ml.Methods
This study was a prospective pilot trial with 6-months follow-up. Fourteen glaucoma patients underwent trabeculectomy revision with OLO. Primary outcome measures included postoperative target intraocular pressure (IOP), with or without medications. Secondary outcome measures included bleb evaluation, OCT imaging, number of medications, number of postoperative interventions and adverse events. All patients were reviewed postoperatively at day 1, 7, week 3, 7, 12 and 24.Results
The mean pre-operative IOP was 22.3 (±4.1 mmHg), mean postoperative IOP was 14 (±5.8 mmHg). IOP reduction from baseline was statistically significant (p<0.05). The bleb remained well formed and functioning in all patient at all postoperative reviews. OCT imaging allowed monitoring of the position of OLO implant and showed a progressive decrease in thickness from week 1 to week 7. No serious events were observed.Conclusion
The trial showed that trabeculectomy revision with OLO implant was safe and achieved a success rate similar to trabeculectomy revision with MMC.