One Year Hospita L Based Longitudinal Study To Know The Safety And Efficacy Of Minimal Dose Of Mitomycin–C In Trabeculectomy

Abstract

Background and objectives: Glaucoma ranks second as the most common cause of blindness worldwide. Treatment of glaucoma is usually by medical therapy but in certain situations like poor compliance, lack of awareness, poor follow-up facilities and non-affordability, surgical intervention becomes the method of first choice. Glaucoma surgery has many sight threatening complications and a high risk of failure. The cause of failure in these cases is scarring due to proliferation of fibroblasts at the surgical site .so, to increase the success rates in the glaucoma filtration surgeries, antifibrotic agents are being used to modulate wound healing. However,it can cause increased risk of serious complications. The optimum regimen of Mitomycin-C administration has yet to be established. It is known that this anti-proliferative agent acts in a dose and time dependent way.So the study is aimed to establish the safety and efficacy of minimal dose of Mitomycin-C in trabeculectomy. The aim of this study is to evaluate the safety of minimal concentration and exposure time of Mitomycin-C (0.1mg/ml for 2 minutes) as an adjunct to trabeculectomy and to evaluate the complications of minimal dose of mitomycin-c in trabeculectomy. Methodology The present one year longitudinal study was conducted in the Department of Ophthalmology, KLES Dr. Prabhakar Kore hospital and Medical Research Centre, Belagavi on patients undergoing glaucoma filtering surgery during the period of 1st January 2015-31st December 2015. The study was approved by the Ethical and Research Committee of Jawaharlal Nehru Medical College, Belagavi. Thirty patients with low risk glaucoma underwent a complete ophthalmic assessment and then underwent trabeculectomy with 0.01mg/ml (for two minutes) Mitomycin-C .Visual acuity, bleb function and related complications, intra ocular pressure and any other complications were noted post operatively till three months. Results : -30 eyes of 30 patients has been undergone trabeculectomy with MMC or trabeculectomy with MMC with SICS with PCIOL. -out of thirty patients, maximum number of patients(12 patients) were between 46-60 years age group, two patients belonged to 31-45 years age group, eleven patients belonged to 61-75 years age group and five patients were above 76 years. -There were 21 male patients and 9 female patients. -15 patients with POAG, 4 patients with CACG, 11 patients with pseudoexfoliative glaucoma underwent glaucoma filteration surgery. -15 patients underwent trabeculectomy with MMC and 15 patients underwent SICS with PCIOL with trabeculectomy with MMC. -On application of student “t” test it was statistically significant. (P<0.001) -The initial IOP of 21 patients was between 21-30mmhg and IOP of 9 patients was between 31-55mmhg. -The mean pre-op IOP was 30.18± 9.68 and mean IOP at the end of one day, one week, one month and three months was 11.65 ± 5.24,11.64±5.46,11.95±4.48 and 10.97±3.84 respectively. -Complete success (IOP was less than 21 mm Hg without glaucoma medication) was observed in 90 % of cases and qualified success (IOP was less than 21 mm Hg with or without glaucoma medication) was noted in 10% of cases. -VA was stable or improved in 93.3%. In 6.6% patients ( 3patients), VA was reduced because of cataract or pre-existing cataract (one patient- 3.33%) and choroidal detachment(one patient-3.33%) -In one patient(3.33%), shallow AC was noted. - The most common variety of bleb encountered was grade II or diffuse, mildly elevated and normally vascularised filtering bleb (according to Moorfield’s classification) seen in 28cases (93.3%),in the last follow up. In 1 case (3.3%) we encountered grade I or diffuse, avascular, mildly elevated filtering bleb and in 1 case grade III or diffuse, mildly elevated and mildly vascularised bleb was encountered. (3.3%) Conclusion and interpretation: Intraoperative application of MMC in low doses (0.1mg/ml x 2 minutes) was associated with better control of IOP, stabilization of visual acuity, well functioning normally vascularised blebs, with minimal acceptable complications and can be used as a safe and efficacious adjuvant in primary filtering surgeries in low risk cases.