Comparison of face-down and seated position after idiopathic macular hole surgery: a randomized clinical trial. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial.
To compare two therapeutic modalities on anatomic and functional results after idiopathic macular hole (MH) surgery: seated vs face-down position.
                Multicenter, prospective, randomized trial.
                Setting: University Hospital Dijon and University Hospital Nancy. Patients: One hundred and forty-four patients (150 eyes) were enrolled and randomly separated into two groups for postoperative position: for the 72 eyes in the P0 group and the 78 eyes in the P1 group, the patients were asked to keep the seated (P0 group) and the face-down position (P1 group) after the idiopathic MH surgery. Intervention: All patients underwent a complete vitrectomy with a fluid-air exchange and an intraocular gas tamponade. After the surgery, patients were asked to keep one of the two randomly chosen positions for five days. Main Outcome Measures: Best-corrected visual acuity (VA), fundus examination, and macular optical coherence tomography were performed before and six months after surgery.
                The overall anatomic success rate was 92.7%. The idiopathic MH sealed in 63 of 72 P0 eyes (87.5%) and 76 of 78 P1 eyes (97.4%) (P = .027). The mean VA increased from 0.86 to 0.61 logMAR (0.88 to 0.61 in P0 and 0.84 to 0.60 in P1). However, in a post hoc analysis based on the size of the idiopathic MH, the success rate in idiopathic MHs smaller than 400 microm was not influenced by the postoperative position (P = .47).
                A face-down postoperative position is highly recommended in holes larger than 400 microm. The size of the idiopathic MH seems to be an important factor affecting outcome. To determine the effect of internal limiting membrane (ILM) peeling on anatomical and functional success rates in stage 2 and 3 idiopathic macular hole surgery (MHS).
                Randomised clinical trial of stage 2 and 3 idiopathic macular hole without visible epiretinal fibrosis and with less than 1 year's duration of symptoms. Eyes were randomised to (1) vitrectomy alone without retinal surface manipulation, (2) vitrectomy plus 0.05% isotonic Indocyanine Green (ICG)-assisted ILM peeling or (3) vitrectomy plus 0.15% Trypan Blue (TB)-assisted ILM peeling. Main outcomes were hole closure after 3 and 12 months and best-corrected visual acuity after 12 months.
                78 eyes were enrolled. Primary closure rates were significantly higher with ILM peeling than without peeling for both stage 2 holes (ICG peeling 100%, non-peeling 55%, p = 0.014) and for stage 3 holes (ICG peeling 91%, TB peeling 89%, non-peeling 36%, p<0.001). Visual outcomes in eyes with primary hole closure were not significantly different between the groups.
                Dye-assisted ILM peeling was associated with significantly higher closure rates than non-peeling in both stage 2 and 3 MHS. Intraoperative ILM staining with 0.05% isotonic ICG was not associated with a significantly different visual outcome than non-peeling or TB peeling in eyes with primary hole closure. Trial registration number: NCT00302328.
There is currently insufficient evidence from which to draw firm conclusions about the impact of postoperative face-down positioning on the outcome of surgery for macular hole. Of three RCTs, two suggested a benefit in larger holes but none demonstrated evidence of a benefit in smaller holes.
CONSORT adherent RCTs and large scale, well designed non-randomised observational studies are needed to determine with confidence the value of this intervention.