Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless, Intrascleral, 1-Piece Intraocular Lens Fixation:...

Area of Science:

• Ophthalmology
• Surgical Innovation
• Medical Device Technology

Background:

• Secondary intraocular lens (IOL) implantation is necessary in eyes lacking adequate capsular support.
• Sutureless intrascleral fixation offers a potentially safer alternative to traditional fixation methods.
• Evaluating long-term outcomes of novel IOL designs is crucial for clinical adoption.

Purpose of the Study:

• To assess the 2-year visual, refractive, and anatomical outcomes of a specific foldable single-piece intraocular lens (IOL).
• The IOL is designed for sutureless intrascleral fixation in eyes without sufficient capsular support.
• This study aims to validate the efficacy and safety of this technique for secondary IOL implantation.

Main Methods:

• A prospective, observational, multicenter study was conducted involving 234 eyes of 232 patients.
• A standardized sutureless intrascleral fixation technique using a scleral flap was employed for all IOL implantations.
• Key outcomes including best-corrected visual acuity (BCVA), refractive error, and endothelial cell density (ECD) were monitored over 24 months.

Main Results:

• Mean BCVA significantly improved from 0.74 to 0.26 logMAR (P < 0.001) at 24 months.
• Refractive prediction error within ±1.00 D was achieved in 77% of eyes, with stable outcomes.
• No significant changes in IOL tilt, decentration, or ECD were observed, and complication rates were low.

Conclusions:

• Sutureless intrascleral fixation of this single-piece foldable IOL yields sustained visual gains and high refractive accuracy.
• The technique demonstrates stable anatomical positioning and a favorable safety profile over 24 months.
• This method is well-tolerated and effective for secondary IOL implantation in eyes with compromised capsular support.