Outcome after treatment of ametropia with implantable contact lenses.

Objective: To evaluate long-term results after insertion of implantable contact lenses (ICLs) in phakic eyes.

Design: Prospective, noncomparative, interventional case series.

Participants: Seventy-five phakic eyes (65 myopic, 10 hyperopic eyes) of 45 patients aged 21.7 to 60.6 years were included.

Intervention: STAAR Collamer Implantable Contact Lenses (STAAR Surgical Inc., Nidau, Switzerland) were implanted for correction of high myopia and hyperopia.

Main Outcome Measures: Uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were determined. Presence of lens opacification and the distance between the ICL and the crystalline lens were assessed by slit-lamp examination before surgery and at 1, 3, 6 months, and yearly after lens implantation.

Results: Preoperative mean spherical equivalent was -16.23+/-5.29 diopters (D) for myopic eyes and +7.88 +/-1.46 D for hyperopic eyes. After ICL implantation, mean residual refractive error was -1.77+/-2.17 D in myopic patients and +0.44+/-0.69 D in hyperopic patients. Preoperative mean UCVA was Snellen 0.03+/-0.03 for myopic patients and Snellen 0.12+/-0.16 for hyperopic patients. Preoperative mean BCVA was Snellen 0.49+/-0.23 for myopic patients and Snellen 0.82+/-0.23 for hyperopic patients. After ICL implantation, mean UCVA up to the end of individual observation time was Snellen 0.36+/-0.36 for myopic patients and Snellen 0.58+/-0.28 for hyperopic patients. Mean BCVA was Snellen 0.73+/-0.26 for myopic and Snellen 0.80+/-0.24 for hyperopic patients. Mean preoperative IOP was 14.2+/-2.7 mmHg, and mean postoperative IOP was 13.46+/-2.1 mmHg over all follow-up investigations. The main complication was the development of subcapsular anterior opacifications of the crystalline lens in 25 eyes (33.3%), 2 of which showed direct contact to the ICL. Eleven eyes (14.7%) were stable in opacification and 14 eyes (18.7%) had progressive opacifications. The median time to opacification was 27.1 months. In 8 patients (10.7%), the subjective visual impairment mandated cataract surgery.

Conclusions: The most significant long-term complication after ICL implantation is the formation of opacifications of the crystalline lens with the risk of the necessity of subsequent cataract surgery (10.7%). Old age, female gender, and contralateral opacification are independent significant risk factors for early formation of opacifications in this patient group.