Pierre-Henry Gabrielle1,2, Pascale Massin3, Laurent Kodjikian4, Ali Erginay3, Charlotte Pallot1,2, Lysiane Jonval5, Agnès Soudry5, Aude Couturier3, Cristina Vardanian-Vartin4, Alain M Bron1,2, Catherine Creuzot-Garcher1,2. 1. Department of Ophthalmology, University Hospital, Dijon, France. 2. Eye and Nutrition Research Group, Centre des Sciences du Goût et de l'Alimentation, UMR1324 INRA, 6265 CNRS, University of Bourgogne Franche-Comté, Dijon, France. 3. Department of Ophthalmology, Hôpital Lariboisière, AP-HP, Université Paris 7 - Sorbonne Paris Cité, Paris, France. 4. Department of Ophthalmology, Croix-Rousse teaching Hospital, Hospices Civil de Lyon, Lyon, France. 5. Department of Clinical Research and Epidemiology, University Hospital, Dijon, France.
Abstract
PURPOSE: To compare central retinal thickness (CRT) after panretinal photocoagulation (PRP) with a multispot semi-automated PAttern-SCAnning Laser (PASCAL) in one session (SS-PRP) versus four monthly sessions (MS-PRP) in diabetic retinopathy. METHODS: Multicentre, prospective, randomized, single-blinded, controlled trial evaluating the noninferiority of SS-PRP versus MS-PRP for CRT measured with macular spectral-domain optical coherence tomography (SD-OCT), with a 9-month follow-up in patients presenting severe nonproliferative diabetic retinopathy (DR) or mild proliferative DR without macular oedema (ME) at baseline. RESULTS:Ninety-seven eyes of 97 participants with a mean age of 57.0 ±14.2 years were included. The mean change of CRT from baseline to 9 months was not statistically different in SS-PRP or in MS-PRP: +16.9 ± 28.3 μm versus +24.7 ± 31.8 μm, respectively (p = 0.224). The variation in mean best-corrected visual acuity (BCVA) from baseline to 9 months was similar in both groups: -1.1 ± 6.5 letters versus -0.6 ± 6.2 letters (p = 0.684). The number of patients with stabilization of DR was not statistically different between the two groups. No severe complication was recorded in either group. CONCLUSION: This study showed the noninferiority of PRP performed in one session versus four monthly sessions with a PASCAL concerning central retinal thickness for treating mild proliferative or severe nonproliferative DR without ME at baseline.
RCT Entities:
PURPOSE: To compare central retinal thickness (CRT) after panretinal photocoagulation (PRP) with a multispot semi-automated PAttern-SCAnning Laser (PASCAL) in one session (SS-PRP) versus four monthly sessions (MS-PRP) in diabetic retinopathy. METHODS: Multicentre, prospective, randomized, single-blinded, controlled trial evaluating the noninferiority of SS-PRP versus MS-PRP for CRT measured with macular spectral-domain optical coherence tomography (SD-OCT), with a 9-month follow-up in patients presenting severe nonproliferative diabetic retinopathy (DR) or mild proliferative DR without macular oedema (ME) at baseline. RESULTS: Ninety-seven eyes of 97 participants with a mean age of 57.0 ± 14.2 years were included. The mean change of CRT from baseline to 9 months was not statistically different in SS-PRP or in MS-PRP: +16.9 ± 28.3 μm versus +24.7 ± 31.8 μm, respectively (p = 0.224). The variation in mean best-corrected visual acuity (BCVA) from baseline to 9 months was similar in both groups: -1.1 ± 6.5 letters versus -0.6 ± 6.2 letters (p = 0.684). The number of patients with stabilization of DR was not statistically different between the two groups. No severe complication was recorded in either group. CONCLUSION: This study showed the noninferiority of PRP performed in one session versus four monthly sessions with a PASCAL concerning central retinal thickness for treating mild proliferative or severe nonproliferative DR without ME at baseline.