OBJECTIVE: To establish whether the success rate of surgery for small idiopathic macular holes (diameter, ≤ 400 μm) is significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. DESIGN: Randomized, controlled, parallel-assignment, open-label, interventional, multicenter clinical trial. PARTICIPANTS: Sixty-nine patients from 6 specialized vitreoretinal units, randomized into 2 parallel groups and followed up after surgery for 3 months. METHODS: All patients underwent pars plana vitrectomy, peeling of any epiretinal membrane, and 17% C₂F₆ gas filling. Patients then were advised randomly to observe either strict facedown positioning for 22 of 24 hours or simply to avoid the supine position for 10 days. MAIN OUTCOME MEASURES: The primary outcome measure was the rate of anatomic closure 3 months after surgery. Main secondary measurements included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, progression of cataract, and frequency of complications. RESULTS: The mean size of macular holes was approximately 300 μm in both groups. Closure rates were more than 90% in both groups: 32 (91.4%) of 34 eyes in the alleviated positioning group versus 32 (94.1%) of 35 eyes in the facedown positioning group (lower margin of 95% confidence interval of difference, -14.88%). The ETDRS scores at 3 months increased in both groups by 10.23 ± 14.64 and 10.52 ± 14.54 letters, respectively. Progression of cataract and the rate of other complications were not significantly different in the 2 groups. CONCLUSIONS: The success rate of surgery for idiopathic macular holes of 400 μm or smaller is not significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. These macular holes can be treated by streamlined surgery, that is, with no internal limiting membrane peeling and no facedown positioning (only avoidance of the supine position) with a closure rate of more than 90% and a mean gain in visual acuity of more than 2 ETDRS lines at 3 months.
RCT Entities:
OBJECTIVE: To establish whether the success rate of surgery for small idiopathic macular holes (diameter, ≤ 400 μm) is significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. DESIGN: Randomized, controlled, parallel-assignment, open-label, interventional, multicenter clinical trial. PARTICIPANTS: Sixty-nine patients from 6 specialized vitreoretinal units, randomized into 2 parallel groups and followed up after surgery for 3 months. METHODS: All patients underwent pars plana vitrectomy, peeling of any epiretinal membrane, and 17% C₂F₆ gas filling. Patients then were advised randomly to observe either strict facedown positioning for 22 of 24 hours or simply to avoid the supine position for 10 days. MAIN OUTCOME MEASURES: The primary outcome measure was the rate of anatomic closure 3 months after surgery. Main secondary measurements included Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, progression of cataract, and frequency of complications. RESULTS: The mean size of macular holes was approximately 300 μm in both groups. Closure rates were more than 90% in both groups: 32 (91.4%) of 34 eyes in the alleviated positioning group versus 32 (94.1%) of 35 eyes in the facedown positioning group (lower margin of 95% confidence interval of difference, -14.88%). The ETDRS scores at 3 months increased in both groups by 10.23 ± 14.64 and 10.52 ± 14.54 letters, respectively. Progression of cataract and the rate of other complications were not significantly different in the 2 groups. CONCLUSIONS: The success rate of surgery for idiopathic macular holes of 400 μm or smaller is not significantly reduced if facedown positioning is replaced by simply taking care to avoid the supine position. These macular holes can be treated by streamlined surgery, that is, with no internal limiting membrane peeling and no facedown positioning (only avoidance of the supine position) with a closure rate of more than 90% and a mean gain in visual acuity of more than 2 ETDRS lines at 3 months.
Authors: Alfredo García-Layana; José García-Arumí; José M Ruiz-Moreno; Lluís Arias-Barquet; Francisco Cabrera-López; Marta S Figueroa Journal: J Ophthalmol Date: 2015-03-03 Impact factor: 1.909