PURPOSE: To determine if intraocular infusion of low-molecular-weight heparin (enoxaparin) reduces postoperative inflammation in pediatric eyes undergoing cataract surgery with IOL implantation. DESIGN: Prospective masked randomized controlled trial. METHODS: setting: Private, institutional practice. study population: Twenty children (40 eyes) undergoing bilateral cataract surgery with IOL implantation were randomized to receive enoxaparin in the intraocular infusion fluid (BSS) (Group I) or not to receive enoxaparin (Group II). The first eye was randomly assigned to 1 of the 2 groups and the second eye received alternate treatment. observation procedure: Patients were followed up in the first week and 1 and 3 months after surgery. main outcome measures: Anterior chamber flare and cells (Hogan's criteria), cell deposits on IOL, posterior synechiae. RESULTS: One week postoperatively, no eyes had >grade 2 flare/cells. Proportion of eyes with grade 2 cells was higher in eyes that did not receive enoxaparin (Group II: 80% vs Group I: 40%, P = .009). In the first week >10 small cell deposits were noted in the eyes that received enoxaparin (Group I: 20%, Group II: none, P = .005). Large cell deposits first appeared at 1 month in 40% of eyes in Group I and 55% of eyes in Group II (P = .34) and increased at 3 months (60% in both groups, P > .999). Posterior synechiae were seen in 10% of eyes in Group I at 1 month, which persisted at 3 months; no eyes in Group II showed posterior synechiae (P = .14). CONCLUSION: The results of our study suggest that there does not seem to be a benefit of using enoxaparin in the infusion fluid with respect to early postoperative inflammation.
RCT Entities:
PURPOSE: To determine if intraocular infusion of low-molecular-weight heparin (enoxaparin) reduces postoperative inflammation in pediatric eyes undergoing cataract surgery with IOL implantation. DESIGN: Prospective masked randomized controlled trial. METHODS: setting: Private, institutional practice. study population: Twenty children (40 eyes) undergoing bilateral cataract surgery with IOL implantation were randomized to receive enoxaparin in the intraocular infusion fluid (BSS) (Group I) or not to receive enoxaparin (Group II). The first eye was randomly assigned to 1 of the 2 groups and the second eye received alternate treatment. observation procedure: Patients were followed up in the first week and 1 and 3 months after surgery. main outcome measures: Anterior chamber flare and cells (Hogan's criteria), cell deposits on IOL, posterior synechiae. RESULTS: One week postoperatively, no eyes had >grade 2 flare/cells. Proportion of eyes with grade 2 cells was higher in eyes that did not receive enoxaparin (Group II: 80% vs Group I: 40%, P = .009). In the first week >10 small cell deposits were noted in the eyes that received enoxaparin (Group I: 20%, Group II: none, P = .005). Large cell deposits first appeared at 1 month in 40% of eyes in Group I and 55% of eyes in Group II (P = .34) and increased at 3 months (60% in both groups, P > .999). Posterior synechiae were seen in 10% of eyes in Group I at 1 month, which persisted at 3 months; no eyes in Group II showed posterior synechiae (P = .14). CONCLUSION: The results of our study suggest that there does not seem to be a benefit of using enoxaparin in the infusion fluid with respect to early postoperative inflammation.