Dissociated optic nerve fiber layer appearance after macular hole surgery: a randomized controlled trial comparing the temporal inverted internal limiting membrane flap technique versus conventional peeling
Abstract
PURPOSE
To evaluate the effect of the temporal inverted internal limiting membrane (ILM) flap technique compared to conventional ILM peeling on the extent of dissociated optic nerve fiber layer (DONFL) and the retinal sensitivity in patients undergoing macular hole (MH) surgery.
DESIGN
Single-center, prospective, open-label randomized controlled clinical trial PARTICIPANTS: Patients requiring vitrectomy for MH > 250 μm METHODS: Patients were randomly assigned (1/1) to one of the two groups: the control group undergoing standard ILM peeling and the experimental group (flap group) undergoing the temporal inverted ILM flap technique.
MAIN OUTCOME MEASURES
The primary outcome measure was the total DONFL score at 3 months after surgery. Important secondary outcomes were microperimetry results, primary MH closure rate, rates of external limiting membrane (ELM) and ellipsoid zone (EZ) recovery and best-corrected visual acuity (BCVA).
RESULTS
Sixty-five patients were recruited between February 2018 and July 2020; 60 patients had primary outcome data. The median DONFL score was 7.0 (3.0-12.5) in the control group and 5.0 (1.5-8.5) in the flap group at 3 months postoperatively (p=0.145). The focal depressions characteristics of DONFL were limited to the temporal side of the fovea in the flap group, while they were found all around the fovea in the control group on SD-OCT images. The MH closure rate, EZ and ELM recovery rates, and BCVA were similar between the 2 groups (p=1, p=0.252…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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