Objective: To report on anatomical and visual outcomes after vitrectomy and internal limiting membrane peeling for idiopathic macular hole repair.
Methods: Forty patients with stage II to IV idiopathic macular holes were randomly assigned (1:1) in a 2-arm, single-center, randomized controlled . Internal limiting membrane delamination was performed using indocyanine green (ICG) solution (n = 20) or trypan blue (TB) (n = 20). Two patients did not complete the study, for a total of 19 in each group. Follow-up examinations included Early Treatment of Diabetic Retinopathy Study visual acuity, scanning laser ophthalmoscope microperimetry, optical coherence tomography, and fluorescein angiography. Main Outcome Measure Visual acuity 3 months after surgery.
Results: Visual acuity did not show a significant difference between study groups (95% confidence interval [CI], -2 to 1 lines). The rate of macular hole closures was identical (84%; 95% CI, 60% to 97%). Within-group visual recovery was significant only in the TB group. Central scotomata despite hole closure persisted in 8 patients (42%) in the ICG group and in 5 (26%) in the TB group.
Conclusion: Although no statistically significant difference was detected for the primary end point, the better visual recovery in the TB group and the higher rate of persistent central scotomata in the ICG group justify a larger clinical trial. Application to Clinical Practice No statistically significant difference in visual acuity between ICG and TB in the used concentrations and application method could be proved in macular hole surgery.
Trial registration: ClinicalTrials.gov NCT00419185.