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Related Experiment Video

Updated: Jul 2, 2025

Author Spotlight: Enhancing Visual Outcomes in Cataract Surgery: A Novel Technique to Prevent Posterior Capsular Opacification Through IOL Rotation
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Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS)

Soujanya Kaup1,2, Dimple Kondal3,4, Siddharudha Shivalli5

  • 1Department of Ophthalmology, Yenepoya Medical College Hospital, Yenepoya Deemed to be University, Mangalore, Karnataka, 575018, India. drsoujanyak@gmail.com.

Trials
|February 23, 2024
PubMed
Summary

This study investigates phaco tip position during cataract surgery to minimize corneal endothelial cell damage. Findings will guide surgical techniques for better visual outcomes.

Keywords:
Bevel-downBevel-upEndothelial cell lossPhaco-tipPhacoemulsificationPhacoemulsification/complicationPseudophakic bullous keratopathySpecular microscopy

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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.