Olav Kristianslund1, Marianne Råen2, Atle E Østern2, Liv Drolsum3. 1. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway. Electronic address: olav.kristianslund@gmail.com. 2. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. 3. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Abstract
PURPOSE: To compare the efficacy and safety of 2 operation methods for late in-the-bag intraocular lens (IOL) dislocation. DESIGN: Prospective, randomized, parallel-group surgical trial. PARTICIPANTS: Patients referred to Oslo University Hospital (tertiary referral center). METHODS: We randomly assigned 104 patients (104 eyes) either toIOL repositioning by scleral suturing (n = 54) or to IOL exchange with retropupillary fixation of an iris-claw IOL (n = 50). One surgeon performed all operations. Patients were evaluated comprehensively before surgery, and most patients (82%) attended an examination 6 months after surgery. MAIN OUTCOME MEASURES: Best-corrected visual acuity (BCVA) 6 months after surgery. RESULTS: The mean postoperative BCVA was 0.24±0.29 logarithm of the minimum angle of resolution (logMAR) units (range, -0.18 to 1.16 logMAR) in the repositioning group and 0.35±0.54 logMAR (range, -0.20 to 3.0 logMAR) in the exchange group (P = 0.23). A BCVA of 20/40 or better (Snellen) was reached by 61% and 62% of the patients, respectively (P = 0.99). The mean postoperative corneal cylinder was 1.2±1.0 and 1.2±0.8 diopters, respectively (P = 0.84), and the postoperative endothelial cell density changes were -3±10% (P = 0.07) and -10±14% (P = 0.001), respectively (group difference, P = 0.04). Repositioning had a longer mean surgical time than exchange (P < 0.001). There were 2 (4%) and 0 cases of perioperative fluid misdirection syndrome, respectively. Postoperative complications were intraocular pressure (IOP) increase (n = 12), cystoid macular edema (CME; n = 3), and nonarteritic anterior ischemic optic neuropathy (n = 1) in the repositioning group, and IOP increase (n = 9), pupillary block (n = 1), choroidal effusion (n = 2), CME (n = 4), and redislocation (n = 1) in the exchange group. CONCLUSIONS: We found satisfactory and not significantly different outcomes for BCVA 6 months after surgery in the 2 groups. Both operation methods seemed safe, with low frequencies of serious perioperative and postoperative complications. However, some of the observed differences in complications should be taken into consideration when selecting the most suitable method in clinical practice.
RCT Entities:
PURPOSE: To compare the efficacy and safety of 2 operation methods for late in-the-bag intraocular lens (IOL) dislocation. DESIGN: Prospective, randomized, parallel-group surgical trial. PARTICIPANTS: Patients referred to Oslo University Hospital (tertiary referral center). METHODS: We randomly assigned 104 patients (104 eyes) either to IOL repositioning by scleral suturing (n = 54) or to IOL exchange with retropupillary fixation of an iris-claw IOL (n = 50). One surgeon performed all operations. Patients were evaluated comprehensively before surgery, and most patients (82%) attended an examination 6 months after surgery. MAIN OUTCOME MEASURES: Best-corrected visual acuity (BCVA) 6 months after surgery. RESULTS: The mean postoperative BCVA was 0.24±0.29 logarithm of the minimum angle of resolution (logMAR) units (range, -0.18 to 1.16 logMAR) in the repositioning group and 0.35±0.54 logMAR (range, -0.20 to 3.0 logMAR) in the exchange group (P = 0.23). A BCVA of 20/40 or better (Snellen) was reached by 61% and 62% of the patients, respectively (P = 0.99). The mean postoperative corneal cylinder was 1.2±1.0 and 1.2±0.8 diopters, respectively (P = 0.84), and the postoperative endothelial cell density changes were -3±10% (P = 0.07) and -10±14% (P = 0.001), respectively (group difference, P = 0.04). Repositioning had a longer mean surgical time than exchange (P < 0.001). There were 2 (4%) and 0 cases of perioperative fluid misdirection syndrome, respectively. Postoperative complications were intraocular pressure (IOP) increase (n = 12), cystoid macular edema (CME; n = 3), and nonarteritic anterior ischemic optic neuropathy (n = 1) in the repositioning group, and IOP increase (n = 9), pupillary block (n = 1), choroidal effusion (n = 2), CME (n = 4), and redislocation (n = 1) in the exchange group. CONCLUSIONS: We found satisfactory and not significantly different outcomes for BCVA 6 months after surgery in the 2 groups. Both operation methods seemed safe, with low frequencies of serious perioperative and postoperative complications. However, some of the observed differences in complications should be taken into consideration when selecting the most suitable method in clinical practice.