A randomised controlled trial evaluating internal limiting membrane peeling forceps in macular hole surgery

Area of Science:

• Ophthalmology
• Retinal Surgery
• Surgical Instrumentation

Background:

• Internal limiting membrane (ILM) peeling is a crucial step in idiopathic full-thickness macular hole (FTMH) surgery.
• Standard forceps used for ILM peeling may cause iatrogenic retinal damage.
• Novel forceps designed for atraumatic ILM pick-up aim to minimize retinal injury.

Purpose of the Study:

• To evaluate anatomical and functional outcomes after ILM peeling using novel etched-tip forceps versus standard smooth-tip forceps.
• To assess the safety and efficacy of atraumatic ILM pick-up forceps in FTMH surgery.

Main Methods:

• A masked, proof-of-concept randomized controlled trial (RCT) involving 65 patients with FTMH.
• Patients were randomized to undergo ILM peeling with either etched-tip forceps (33 eyes) or standard smooth-tip forceps (32 eyes).
• Postoperative assessments included visual acuity, visual field, and retinal imaging at multiple time points up to 6 months.

Main Results:

• The primary closure rate was high at 95.4%.
• No statistically significant differences were observed between the groups in final visual acuity, visual field mean deviation, or incidence of retinal hemorrhages.
• Similar rates of nerve fiber layer lesions and inner retina defects were noted, with a trend towards lower reduction in inner retinal volume in the inferior sector for the etched-tip group.

Conclusions:

• The study was successfully completed with maintained masking and low risk of bias.
• While not powered for specific endpoint detection, the study found no significant differences in assessed anatomical and functional outcomes between the two forceps types.
• The findings provide valuable estimates for sample size calculations in future studies comparing ILM peeling techniques.