Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial.

Area of Science:

• Ophthalmology
• Surgical Innovation
• Clinical Trials

Background:

• Idiopathic full-thickness macular holes require surgery for closure.
• Face-down positioning is advised post-surgery to enhance closure rates, but patient adherence is challenging.
• Evidence supporting the efficacy of face-down positioning for macular hole closure is limited.

Purpose of the Study:

• To evaluate the effectiveness of post-operative face-down positioning in improving surgical success rates for large macular holes (≥400 microm).
• To compare outcomes between patients advised to maintain face-down positioning versus those in a face-forward position.

Main Methods:

• A multicentre, parallel-group, superiority randomized controlled trial (PIMS trial) involving 192 patients.
• Patients with large macular holes were randomized to either face-down or face-forward positioning for at least 8 hours daily for 5 days post-surgery.
• Primary outcome: successful macular hole closure at 3 months. Secondary outcomes included re-operation rates, visual acuity, and patient-reported outcomes (VFQ-25).

Main Results:

• The primary outcome is successful macular hole closure at 3 months post-surgery.
• Treatment effect will be reported as an odds ratio, adjusted for macular hole size and phakic lens status.
• Secondary outcomes include rates of further surgery, patient-reported experience, and visual function.

Conclusions:

• The PIMS trial is the first multicentre randomized controlled trial to assess face-down positioning after standardized macular hole surgery.
• Findings will provide crucial evidence to guide clinical practice regarding post-operative positioning for macular hole repair.