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Describe and compare the effects of intraoperative application of Polyvinylpyrrolidone Collagen(PVP) versus Mitomycin C(MMC) in IOP and number of medications reduction over a 36-month follow-up in patients with primary open angle glaucoma(POAG) undergoing trabeculectomy.
Prospective,randomized,comparative study.Twenty-eight eyes of 28 patients with POAG underwent primary trabeculectomy and were randomized to PVP or MMC and completed a 36-month follow-up.The main outcome measures were IOP and number of glaucoma medications.Multivariate longitudinal analysis was performed by fitting a linear trend model adjusting for baseline response for the IOP outcome and a log-linear regression model with within-subject associations for the number of hypotensive medications outcome.Sensitivity analysis was performed to assess lower and higher order polynomial trends over time in IOP.
Mean IOP reduction was 7.62mmHg(3.05,12.18)in the MMC group and 8.15 mmHg(-0.64,16.95)in the PVP group,mean percentage IOP reduction was 37.09%(15.93, 58.17)and 36.08%(5.16, 67.20)respectively.Mean change in number of medications was -0.92medications(-3.38,+1.54))and -1 medication(-3.12,+1.12)respectively.Both groups had a statistically significant decline in mean IOP(p<0.001),there was no discernible difference between the groups(p=0.5975).Sensitivity analysis showed that a linear trend model is adequate to describe the IOP reduction over the follow-up.Both groups had a significant change in the number of hypotensive medications(p<0.05)with no difference between groups(p=0.2917).
The use of PVP during trabeculectomy achieves and maintains a significant IOP reduction and decreases the number of glaucoma medications.Secondary outcome measures showed a lower incidence of adverse events in the PVP group. We can conclude than PVP collagen can be used as an antifibrotic agent in trabeculectomy with comparable outcomes to MMC and potentially less adverse events.