Clinical Comparison of a Small-Aperture Intraocular Lens Versus a Monofocal Control.

Area of Science:

• Ophthalmology
• Biomedical Engineering

Background:

• Cataract surgery often involves intraocular lens (IOL) implantation to restore vision.
• Presbyopia correction remains a challenge in achieving optimal visual outcomes post-surgery.
• The IC-8 small-aperture (SA) IOL is designed to enhance visual quality by extending the depth of focus.

Purpose of the Study:

• To evaluate the visual acuity, visual quality, and safety of the IC-8 SA IOL in patients undergoing cataract surgery.
• To compare the performance of the IC-8 SA IOL against traditional monofocal/monofocal toric IOLs.

Main Methods:

• A prospective, multicenter, open-label, 12-month clinical study.
• 453 patients were enrolled, receiving either the SA IOL in one eye and a monofocal/toric IOL in the fellow eye (n=343) or bilateral monofocal/toric IOLs (control group, n=110).
• Visual acuity, visual quality, and safety outcomes were assessed at 6 and 12 months.

Main Results:

• The SA IOL group demonstrated superior binocular uncorrected intermediate and near visual acuity (P < .0001) at 6 months.
• Distance visual acuity was comparable between the SA IOL and control groups.
• Contrast sensitivity and safety profiles were similar, with the SA IOL group reporting few visual symptoms.

Conclusions:

• The IC-8 SA IOL provides improved intermediate and near vision, with comparable distance vision and contrast sensitivity.
• The lens is an effective option for presbyopia correction during cataract surgery.
• The SA IOL showed a favorable safety profile with minimal adverse events.