Scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment: a prospective randomized multicenter clinical study.

OBJECTIVE: To compare scleral buckling surgery (SB) and primary pars plana vitrectomy (PPV) in rhegmatogenous retinal detachments of medium complexity.

DESIGN: Prospective randomized multicenter clinical trial (the Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study), separated into phakic or aphakic/pseudophakic eyes. Patients were enrolled over a 5-year period. There was 1-year follow up in the study, and the primary outcome was assessed at 1 year.

PARTICIPANTS: Forty-five surgeons (25 centers, 5 European countries) recruited 416 phakic and 265 pseudophakic patients. Completion of follow-up was achieved in 93% of the phakic and 89% of the pseudophakic patients.

INTERVENTION: Scleral buckling surgery with the potential use of multiple sponges, encircling elements, drainage, and intraocular injections. Primary vitrectomy included 3-port vitrectomy with sulfur hexafluoride-air tamponade; additional SB was left to the surgeon's decision.

MAIN OUTCOME MEASURES: Primary study end point: change in best-corrected visual acuity (BCVA); secondary end points: primary and final anatomical success, proliferative vitreoretinopathy, cataract progression, and number of reoperations.

RESULTS: In the phakic trial, the mean BCVA change was significantly (P = 0.0005) greater in the SB group (SB, -0.71 logarithm of the minimum angle of resolution [logMAR], standard deviation [SD] 0.68; PPV, -0.56 logMAR, SD 0.76). In the pseudophakic trial, changes in BCVA showed a nonsignificant difference of 0.09 logMAR. In phakic patients, cataract progression was greater in the PPV group (P<0.00005). In the pseudophakic group, the primary anatomical success rate (defined as retinal reattachment without any secondary retina-affecting surgery; SB, 71/133 [53.4%]; PPV, 95/132 [72.0%]) was significantly better (P = 0.0020), and the mean number of retina-affecting secondary surgeries (SB, 0.77, SD 1.08; PPV, 0.43, SD 0.85) was lower (P = 0.0032) in the PPV group. Redetachment rates were 26.3% (SB; 55/209) and 25.1% (PPV; 52/207) in the phakic trial and 39.8% (SB; 53/133) and 20.4% (PPV; 27/132) in the pseudophakic trial.

CONCLUSIONS: The study shows a benefit of SB in phakic eyes with respect to BCVA improvement. No difference in BCVA was demonstrated in the pseudophakic trial; based on a better anatomical outcome, we recommend PPV in these patients.