Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS)...

Area of Science:

• Ophthalmology
• Surgical Innovation
• Corneal Science

Background:

• Corneal endothelium damage is a significant cause of poor vision after cataract surgery.
• The optimal phaco tip orientation (bevel-up vs. bevel-down) for corneal protection remains unclear.
• This ambiguity necessitates research into cornea-friendly surgical techniques.

Purpose of the Study:

• To compare the impact of bevel-up versus bevel-down phaco tip orientation on corneal endothelial cell count.
• To evaluate the effect of phaco tip position during phacoemulsification using the direct chop technique.
• To provide evidence-based guidance on phacoemulsification techniques to preserve corneal health.

Main Methods:

• A randomized, multicenter, triple-masked trial (TIPS) involving 480 participants with immature cataracts.
• Participants were allocated 1:1 to either bevel-up or bevel-down phaco tip groups, stratified by cataract grade.
• The primary outcome measured was the endothelial cell count at one month post-surgery.

Main Results:

• The study is designed to determine the difference in postoperative endothelial cell count between the two groups.
• Secondary outcomes include central corneal thickness and intraoperative complications.
• Results are anticipated following database lock in July 2023.

Conclusions:

• The statistical analysis plan (SAP) for the TIPS trial has been finalized.
• The study aims to resolve the debate on the most cornea-friendly phaco tip position.
• Publication of results is expected in late 2023, contributing to surgical best practices.