Rotation of a toric intraocular lens with and without capsular tension ring: data from a multicenter non-inferiority...

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Clinical Research

Background:

• Investigating the clinical outcomes of simultaneous implantation of capsular tension rings (CTR) and toric intraocular lenses (IOLs).
• Focusing on IOL rotation, defined as the change in IOL axis from immediate post-implantation to final position.
• Utilizing data from a multicenter, non-inferiority randomized clinical trial (RCT).

Purpose of the Study:

• To evaluate the clinical outcome, specifically IOL rotation, in patients receiving a toric lens with versus without a capsular tension ring (CTR).
• To determine if CTR implantation affects the rotational stability of toric intraocular lenses.
• To assess secondary endpoints including refractive outcomes and visual acuity.

Main Methods:

• Retrospective re-evaluation of data from a randomized clinical trial (RCT) involving outpatient study sites.
• Stratified analysis of patient cohorts with and without CTR implantation.
• Measurement of lens position at baseline and calculation of postoperative rotation using software; evaluation at three months post-surgery.

Main Results:

• No clinically relevant differences in preoperative characteristics between cohorts with and without CTR.
• Similar primary endpoint incidences (absolute postoperative rotation ≤5 degrees) for both groups (90%).
• Comparable secondary endpoint incidences for cylinder deviation (approx. 46%) and corrected distance visual acuity (CDVA ≥0.8) (approx. 90%).

Conclusions:

• Simultaneous implantation of a capsular tension ring (CTR) with a toric lens does not lead to clinically relevant differences in rotational stability.
• Satisfying rotational stability of toric intraocular lenses was achieved at three months post-implantation, regardless of CTR use.
• The findings support the safety and efficacy of combined CTR and toric IOL implantation.