Claudio Azzolini, (Segrate, Italy), Simone Donati, MD (Varese, Italy)

PURPOSE:

The aim of this multicentric, prospective, randomized study was to evaluate the efficacy of the inner limiting membrane removal and the indocyanine green staining on the outcomes of the surgical treatment of macular pucker.

METHODS:

208 eyes in 208 patients with idiopathic macular pucker in selected italian centers were randomized and included in three groups as type of surgery applied. Macular surgery performed with 20 gauge vitrectomy and clinical evident epiretinal membrane removal (Group I, 69 eyes), further research and removal of Inner Limiting Membrane (Group II, 70 eyes), research and removal of ILM after ICG staining (Group III, 69 eyes). Patients evaluated at baseline and day 1, 7, 30, 90, 180 with complete ophthalmology examination. OCT performed at baseline, at day 30, 90 and 180. Principal outcome was visual acuity, then macular thickness and visual distortion. We applied T student statistical method.

RESULTS:

Mean visual acuity in Group I at baseline was 0.56 LogMar, at day 30: 0.53 LogMar, at day 90: 0.40, at day 180: 0.38; in Group II at baseline was 0.54 LogMar, at day 30: 0.46, at day 90: 0.31, at day 180: 0.36; in Group III at baseline was 0.55 LogMar, at day 30: 0.38, at day 90: 0.31, at day 180: 0.30. The average increase on visual acuity at day 180 was 2.49 lines on Group I, 1.72 lines on Group II and 1.76 Group III. Our study showed a significant
improvement in visual acuity at day 90 and 180 in patients with macular pucker and ILM removal. (P<0.05). At day 90 we had an improvement of visual acuity in patients with macular pucker removal associated with not stained ILM. At day 180 patients with macular pucker removal with stained ILM presented a significant visual acuity recovery.

CONCLUSION:

Our study suggested that stained ILM removal represent a valid choice. The multicenter clinical trial with its interactive web database showed the possibility to limit bias in data collection and surgical treatment, underlining the potential of e-ophthalmology in clinical research. Italian Group of Vitreoretinal Surgery supports the study on creation of the database, on data collection elaboration.