Roxane J Hillier1, Tina Felfeli2, Alan R Berger3, David T Wong3, Filiberto Altomare3, David Dai4, Louis R Giavedoni3, Peter J Kertes5, Radha P Kohly5, Rajeev H Muni6. 1. Department of Ophthalmology, St. Michael's Hospital, Toronto, Canada; Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, Canada; Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom; Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, United Kingdom. Electronic address: roxanehillier@gmail.com. 2. Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, Canada. 3. Department of Ophthalmology, St. Michael's Hospital, Toronto, Canada; Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, Canada. 4. Applied Health Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. 5. Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, Canada; Kensington Vision and Research Center, Toronto, Canada; The John and Liz Tory Eye Centre, Sunnybrook Health Sciences Centre, Toronto, Canada. 6. Department of Ophthalmology, St. Michael's Hospital, Toronto, Canada; Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, Canada; Kensington Vision and Research Center, Toronto, Canada. Electronic address: rajeev.muni@gmail.com.
Abstract
PURPOSE: The optimal surgery to repair rhegmatogenous retinal detachment (RRD) is unknown. The purpose of this trial was to compare outcomes of pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for the management of primary RRD. DESIGN: Prospective, randomized controlled trial. PARTICIPANTS: Patients with RRD demonstrating a single retinal break or a group of breaks in detached retina within 1 clock hour above the 8- and 4-o'clock meridians, with any number, location and size of retinal breaks or lattice degeneration in attached retina. METHODS: Patients were randomized to undergo either PnR or PPV. Macula-on and macula-off patients were assigned to intervention group by stratified randomization and were treated within 24 and 72 hours, respectively. MAIN OUTCOME MEASURES: The primary outcome was 1-year Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA). Important secondary outcomes were subjective visual function (25-item National Eye Institute Visual Function Questionnaire), metamorphopsia score (M-CHARTS), and primary anatomic success. RESULTS:One hundred seventy-six patients were recruited between August 2012 and May 2016. ETDRS VA after PnR exceeded that after PPV by 4.9 letters at 12 months (79.9±10.4 letters vs. 75.0±15.2 letters; P = 0.024). Mean ETDRS VA also was superior for the PnR group compared with the PPV group at 3 months (78.4±12.3 letters vs. 68.5±17.8 letters) and 6 months (79.2±11.1 letters vs. 68.6±17.2 letters). Composite 25-item National Eye Institute Visual Function Questionnaire scores were superior for PnR at 3 and 6 months. Vertical metamorphopsia scores were superior for the PnR group compared with the PPV group at 12 months (0.14±0.29 vs. 0.28±0.42; P = 0.026). Primary anatomic success at 12 months was achieved by 80.8% of patients undergoing PnR versus 93.2% undergoing PPV (P = 0.045), with 98.7% and 98.6%, respectively, achieving secondary anatomic success. Sixty-five percent of phakic patients in the PPV arm underwent cataract surgery in the study eye before 12 months versus 16% in the PnR group (P < 0.001). CONCLUSIONS:Pneumatic retinopexy should be considered the first line treatment for RRD in patients fulfillingPneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) recruitment criteria. Pneumatic retinopexy offers superior VA, less vertical metamorphopsia, and reduced morbidity when compared with PPV.
RCT Entities:
PURPOSE: The optimal surgery to repair rhegmatogenous retinal detachment (RRD) is unknown. The purpose of this trial was to compare outcomes of pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for the management of primary RRD. DESIGN: Prospective, randomized controlled trial. PARTICIPANTS: Patients with RRD demonstrating a single retinal break or a group of breaks in detached retina within 1 clock hour above the 8- and 4-o'clock meridians, with any number, location and size of retinal breaks or lattice degeneration in attached retina. METHODS:Patients were randomized to undergo either PnR or PPV. Macula-on and macula-off patients were assigned to intervention group by stratified randomization and were treated within 24 and 72 hours, respectively. MAIN OUTCOME MEASURES: The primary outcome was 1-year Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA). Important secondary outcomes were subjective visual function (25-item National Eye Institute Visual Function Questionnaire), metamorphopsia score (M-CHARTS), and primary anatomic success. RESULTS: One hundred seventy-six patients were recruited between August 2012 and May 2016. ETDRS VA after PnR exceeded that after PPV by 4.9 letters at 12 months (79.9±10.4 letters vs. 75.0±15.2 letters; P = 0.024). Mean ETDRS VA also was superior for the PnR group compared with the PPV group at 3 months (78.4±12.3 letters vs. 68.5±17.8 letters) and 6 months (79.2±11.1 letters vs. 68.6±17.2 letters). Composite 25-item National Eye Institute Visual Function Questionnaire scores were superior for PnR at 3 and 6 months. Vertical metamorphopsia scores were superior for the PnR group compared with the PPV group at 12 months (0.14±0.29 vs. 0.28±0.42; P = 0.026). Primary anatomic success at 12 months was achieved by 80.8% of patients undergoing PnR versus 93.2% undergoing PPV (P = 0.045), with 98.7% and 98.6%, respectively, achieving secondary anatomic success. Sixty-five percent of phakic patients in the PPV arm underwent cataract surgery in the study eye before 12 months versus 16% in the PnR group (P < 0.001). CONCLUSIONS: Pneumatic retinopexy should be considered the first line treatment for RRD in patients fulfilling Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT) recruitment criteria. Pneumatic retinopexy offers superior VA, less vertical metamorphopsia, and reduced morbidity when compared with PPV.
Authors: Rajeev H Muni; Carolina L M Francisconi; Tina Felfeli; Michael Y K Mak; Alan R Berger; David T Wong; Filiberto Altomare; Louis R Giavedoni; Radha P Kohly; Peter J Kertes; Natalia Figueiredo; Fei Zuo; Kevin E Thorpe; Roxane J Hillier Journal: JAMA Ophthalmol Date: 2020-08-01 Impact factor: 7.389
Authors: Koby Brosh; Carolina L M Francisconi; Jenny Qian; Francesco Sabatino; Verena R Juncal; Roxane J Hillier; Varun Chaudhary; Alan R Berger; Louis R Giavedoni; David T Wong; Filiberto Altomare; Mustafa R Kadhim; Richard B Newsom; Samara B Marafon; Rajeev H Muni Journal: JAMA Ophthalmol Date: 2020-06-01 Impact factor: 7.389
Authors: Rajeev H Muni; Tina Felfeli; Srinivas R Sadda; Verena R Juncal; Carolina L M Francisconi; Muneeswar Gupta Nittala; Sophiana Lindenberg; Frederic Gunnemann; Alan R Berger; David T Wong; Filiberto Altomare; Louis R Giavedoni; Radha P Kohly; Peter J Kertes; David Sarraf; Roxane J Hillier Journal: JAMA Ophthalmol Date: 2021-06-01 Impact factor: 7.389
Authors: Nicolas A Yannuzzi; Charles Li; Danielle Fujino; Scott P Kelly; Flora Lum; Harry W Flynn; D Wilkin Parke Journal: JAMA Ophthalmol Date: 2021-06-17 Impact factor: 8.253