Clinical evaluation of the model AT-45 silicone accommodating intraocular lens: results of feasibility and the initial phase of a Food and Drug Administration clinical trial.

OBJECTIVE

To evaluate the clinical outcomes in cataract patients after implantation of an accommodating intraocular lens, designed to move forward and backward along the visual axis.

DESIGN

Prospective, noncomparative case series.

PARTICIPANTS

Sixty-two patients scheduled for small-incision, extracapsular cataract extraction by phacoemulsification.

METHODS

Twenty-eight eyes of 14 patients in the feasibility phase of the study and 48 eyes of 48 patients in the next phase of study underwent cataract extraction and implantation of the AT-45 accommodating intraocular lens. Prospective follow-up was analyzed at 1 month after surgery and compared with baseline characteristics 1 month and 3 to 6 months after surgery.

MAIN OUTCOME MEASURES: Postoperative distance (uncorrected and best corrected), near (uncorrected, through the distance correction, best-corrected, i.e., with add), and intermediate (through the distance correction) visual acuity.

RESULTS

All patients with monocular pseudophakia had best-corrected distance visual acuity of 20/40 or better. Patients with bilateral pseudophakia had best-corrected visual acuity of 20/25 or better when tested binocularly. The results from 28 eyes of 14 patients participating in the feasibility study were combined with those from 48 eyes of 48 patients included in the next phase of the AT-45 study. Uncorrected distance visual acuity was 20/40 or better in most patients (90%, or 56 of 62 eyes implanted and available for follow-up). Ninety-seven percent of patients (60/62) had uncorrected near visual acuity of 20/30 or better. Forty-eight eyes had intermediate visual acuity measured at 28 inches without 'add', and 44 of them (92%) achieved 20/30 or better. No complications or adverse events were reported.

CONCLUSIONS

The AT-45 accommodating intraocular lens, designed to allow movement along the visual axis of the eye by using the natural physiology of the intact ciliary muscle after cataract removal, provides patients with excellent uncorrected distance, intermediate, and near visual acuity and should be considered as a modality to allow the majority of pseudophakic patients to see at all distances without glasses.