Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Medical Devices

Background:

• Cataract surgery requires precise intraocular lens (IOL) placement for optimal visual outcomes.
• Rotational stability of IOLs is critical to maintain astigmatism correction.
• Existing toric IOLs can experience rotation, potentially compromising surgical results.

Purpose of the Study:

• To evaluate and compare the postoperative rotational stability of two novel intraocular lens (IOL) designs (version 1 and version 2) against a control IOL.
• To assess the impact of frosted, squared haptics on IOL rotational stability.
• To determine the safety and handling characteristics of the prototype IOLs.

Main Methods:

• A prospective, multicenter, randomized, paired-eye study over 6 months.
• Bilateral cataract extraction patients (≥22 years) received either version 1 or version 2 IOLs.
• Comparison with a control TECNIS® toric 1-piece monofocal IOL from a separate, similar study.

Main Results:

• Both version 1 and version 2 IOLs demonstrated significantly lower mean absolute rotation at postoperative week 1 compared to the control (0.88° and 0.71° vs. 2.24°, respectively; P < 0.001).
• All eyes with version 1 and version 2 IOLs had <5° rotation at week 1, with no cases >10° observed.
• Surgeons reported acceptable handling, and no device-related adverse events occurred.

Conclusions:

• The novel IOLs (version 1 and version 2) with frosted, squared haptics exhibit superior postoperative rotational stability.
• Version 2, sharing geometry with the current TECNIS toric IOL, was chosen for commercialization due to its performance.
• These findings suggest improved efficacy for astigmatism correction in toric IOLs.