Elsevier

Ophthalmology

Volume 111, Issue 9, September 2004, Pages 1683-1692
Ophthalmology

Original article
United States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: Three-year follow-up

https://doi.org/10.1016/j.ophtha.2004.03.026Get rights and content

Abstract

Purpose

To report on 3-year postoperative safety and efficacy outcomes with the Myopic Implantable Collamer Lens (ICL).

Design

Prospective nonrandomized clinical trial.

Participants

Five hundred twenty-six eyes of 294 patients with between 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia.

Intervention

Implantation of the ICL.

Main outcome measures

Uncorrected visual acuity (VA), refraction, best spectacle-corrected VA (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis, subjective satisfaction, and patient symptoms.

Results

At 3 years, 59.3% had 20/20 or better VA, and 94.7% had 20/40 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emmetropia; 67.5% of patients were within 0.5 D and 88.2% were within 1.0 D of predicted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines. At 3 years postoperatively, 3 eyes (0.8%) decreased by ≥2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensitivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anterior subcapsular opacities (trace or greater) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed nuclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6% reported dissatisfaction; 97.1% of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision, night vision problems, and night driving difficulties decreased or remained unchanged after ICL surgery.

Conclusion

Three-year results from this standardized, multicenter clinical investigation support the safety, efficacy, and predictability of ICL surgery to treat moderate to high myopic refractive errors.

Section snippets

Study design

The US STAAR Myopic ICL clinical study was designed as a prospective, 2-year, multicenter, nonrandomized clinical trial intended to evaluate the safety and efficacy of the ICL to treat moderate to high myopia. The FDA Ophthalmic Devices Advisory Panel, at a recent meeting (August 2, 2002), however, recommended at least a 3-year follow-up for all phakic IOLs before Premarket Approval Application (PMA) submission, so the current study was extended until over 350 eyes had reached the 3-year

Patient population

A detailed description of the Myopic ICL study cohort, which is comprised of 526 eyes of 294 study subjects (3 eyes of 3 patients have been added to the cohort since the previous report1) with preoperative myopia (manifest refraction spherical equivalent [MRSE]) between −3.00 diopters (D) and −20.0 D, was previously reported by the authors.1 Implantable Collamer Lens implantations took place at 14 US clinical investigational sites between November 1998 and December 2002. All eyes received the

Discussion

The FDA granted the ICL file “expedited review” status for high myopia. The FDA's guidance document on expedited review15 states, “Expedited review will generally be considered when a device offers a potential for clinically meaningful benefit as compared to the existing alternatives (preventative, diagnostic, or therapeutic) or when the new medical device promises to provide a revolutionary advance (not incremental advantage) over currently available alternative modalities.” On October 3,

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    The study was funded by STAAR Surgical, Monrovia, California.

    *

    See “Appendix” for group membership.

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