Surgical removal of idiopathic epiretinal membrane with or without the assistance of indocyanine green: a randomised controlled clinical trial

Purpose To carry out a prospective investigation of the functional and morphological outcome of idiopathic epiretinal membrane (IEM) surgery with or without the assistance of indocyanine green (ICG) in a randomised controlled clinical trial. Methods Sixty patients who underwent vitrectomy with removal of IEM combined with cataract surgery were randomly allocated to two groups: 27 patients were operated on with ICG 0.1% in glucose 5%, 33 patients without ICG. Functional outcome was assessed 3-4 months postoperatively with improvement of best-corrected visual acuity (BCVA), Amsler grid test, and automated and kinetic perimetry. Postoperative residual or recurrent IEM was assessed with bio-microscopy, and macular oedema with optical coherence tomography (OCT). Improvement in BCVA was the main outcome measure. Results BCVA improved in 49 patients, remained unchanged in five and decreased in five. Improvement in BCVA and reduction of macular oedema were statistically significant within both groups (P < 0.01). Improvement in BCVA was not statistically significantly different whether ICG was used or not [0.17 (logarithm of minimum angle of resolution; logMAR) with ICG and 0.24 (logMAR) without ICG] (P = 0.59). There was no statistically significant difference in preoperative or postoperative BCVA, reduction of macular oedema, postoperative Amsler grid test, or incidence of residual or recurrent IEM between the two groups. Visual field defects were detected in two patients operated on with ICG. Conclusions Removal of IEM with or without the assistance of ICG equally improved visual function and macular morphology. This study has been registered with , no.: NCT00376857. Presented in part at the 15th Meeting of Societas Ophthalmologica Europaea (SOE), Berlin, Germany, 25–29 September 2005, and at the Annual Meeting of the Association for Research in Vision and Ophthalmology, Fort Lauderdale, Florida, USA, 30 April–4 May 2006.