Jesper H Erichsen1, Julie L Forman, Lars M Holm, Line Kessel. 1. From the Department of Ophthalmology, Rigshospitalet-Glostrup (Erichsen, Holm, Kessel), Glostrup, Section of Biostatistics, Department of Public Health (Forman), Department of Clinical Medicine (Holm, Kessel), University of Copenhagen, Copenhagen, Denmark.
Abstract
PURPOSE: To investigate whether a combination of topical nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids were superior in controlling early postoperative inflammation after cataract surgery compared with topical NSAIDs alone and with dropless surgery where a sub-Tenon depot of steroid was placed during surgery. SETTING: Department of Ophthalmology, Rigshospitalet-Glostrup, Denmark. DESIGN: Prospective randomized controlled trial with masked statistical analyses. METHODS:Patients undergoing phacoemulsification for age-related cataract were randomized to 1 of 5 regimens: ketorolac and prednisolone eyedrops combined (Pred+NSAID-Pre [control group] and Pred+NSAID-Post group) vs ketorolac monotherapy (NSAID-Pre and NSAID-Post groups) vs sub-Tenon depot of dexamethasone (dropless group). Drops were used until 3 weeks postoperatively, starting 3 days preoperatively in the Pre groups and on the day of surgery in the Post groups. Aqueous flare was measured at baseline and 3 days postoperatively. RESULTS:Four hundred fifty-six participants, with a mean age of 72.1 (SD 7.0) years and 283 (62%) women, were included. Flare increased significantly more in the dropless group compared with the control group (Pred+NSAID-Pre), but none of the other groups differed significantly from the control group. Intraocular pressure decreased in all groups but significantly less in groups receiving prednisolone eyedrops (Pred+NSAID-Pre and Pred+NSAID-Post groups) compared with NSAID monotherapy and dropless groups. No differences in postoperative visual acuity were found compared with the control group. CONCLUSIONS: No differences were found between groups randomized to NSAID monotherapy or combination of NSAID and steroid in controlling early inflammation after cataract surgery, but sub-Tenon depot of dexamethasone was less efficient. Initiating prophylactic eyedrops prior to surgery did not influence early postoperative anterior chamber inflammation.
RCT Entities:
PURPOSE: To investigate whether a combination of topical nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids were superior in controlling early postoperative inflammation after cataract surgery compared with topical NSAIDs alone and with dropless surgery where a sub-Tenon depot of steroid was placed during surgery. SETTING: Department of Ophthalmology, Rigshospitalet-Glostrup, Denmark. DESIGN: Prospective randomized controlled trial with masked statistical analyses. METHODS:Patients undergoing phacoemulsification for age-related cataract were randomized to 1 of 5 regimens: ketorolac and prednisolone eyedrops combined (Pred+NSAID-Pre [control group] and Pred+NSAID-Post group) vs ketorolac monotherapy (NSAID-Pre and NSAID-Post groups) vs sub-Tenon depot of dexamethasone (dropless group). Drops were used until 3 weeks postoperatively, starting 3 days preoperatively in the Pre groups and on the day of surgery in the Post groups. Aqueous flare was measured at baseline and 3 days postoperatively. RESULTS: Four hundred fifty-six participants, with a mean age of 72.1 (SD 7.0) years and 283 (62%) women, were included. Flare increased significantly more in the dropless group compared with the control group (Pred+NSAID-Pre), but none of the other groups differed significantly from the control group. Intraocular pressure decreased in all groups but significantly less in groups receiving prednisolone eyedrops (Pred+NSAID-Pre and Pred+NSAID-Post groups) compared with NSAID monotherapy and dropless groups. No differences in postoperative visual acuity were found compared with the control group. CONCLUSIONS: No differences were found between groups randomized to NSAID monotherapy or combination of NSAID and steroid in controlling early inflammation after cataract surgery, but sub-Tenon depot of dexamethasone was less efficient. Initiating prophylactic eyedrops prior to surgery did not influence early postoperative anterior chamber inflammation.
Authors: Tomasz Urbanowicz; Anna Olasińska-Wiśniewska; Michał Michalak; Michał Rodzki; Anna Witkowska; Ewa Straburzyńska-Migaj; Bartłomiej Perek; Marek Jemielity Journal: Biology (Basel) Date: 2021-12-27