Original articleUnited States Food and Drug Administration clinical trial of the Implantable Collamer Lens (ICL) for moderate to high myopia: Three-year follow-up☆
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,
References (33)
- et al.
Phakic posterior chamber lenses for high myopiafunctional and anatomical outcomes
J Cataract Refract Surg
(2000) - et al.
Implantable contact lens for moderate to high myopiashort-term follow-up of 2 models
J Cataract Refract Surg
(2001) - et al.
Collamer intraocular contact lens to correct high myopia
J Cataract Refract Surg
(1996) - et al.
Phakic posterior chamber intraocular lens for the correction of anisometropia and treatment of amblyopia
Am J Ophthalmol
(2000) - et al.
Cataract development after implantation of the Staar Collamer posterior chamber phakic lens
J Cataract Refract Surg
(1999) - et al.
Safety of posterior chamber phakic intraocular lenses for the correction of high myopiaanterior segment changes after posterior chamber phakic intraocular lens implantation
Ophthalmology
(2001) - et al.
Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia
J Cataract Refract Surg
(1998) - et al.
Corneal endothelial assessment after ICL implantation
J Cataract Refract Surg
(2004) - et al.
Risk factors for incident nuclear opacities
Ophthalmology
(2002) U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia
Ophthalmology
(2003)
Posterior chamber phakic intraocular lenses to correct high myopiaa comparative study between STAAR and Adatomed models
J Refract Surg
Posterior chamber collamer phakic intraocular lens for myopia and hyperopia
J Refract Surg
Posterior chamber phakic intraocular lens for myopia of −8 to −19 diopters
J Refract Surg
Phakic posterior chamber plate intraocular lenses for high myopia
J Refract Surg
The Lens Opacities Classification System III
Arch Ophthalmol
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The study was funded by STAAR Surgical, Monrovia, California.
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See “Appendix” for group membership.