There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.
Abstract
To assess the safety and efficacy of the Implantable Contact Lens (ICL) to treat moderate
to high myopia.
Prospective nonrandomized clinical trial.
Five hundred twenty-three eyes of 291 patients with between 3 and 20.0 diopters (D)
of myopia participating in the U. S. Food and Drug Administration clinical trial of
the ICL for myopia.
Implantation of the ICL.
Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity
(BSCVA), adverse events, operative and postoperative complications, lens opacity analysis
(Lens Opacity Classification System III), subjective satisfaction, and symptoms.
Twelve months postoperatively, 60.1% of patients had a visual acuity of 20/20 or better,
and 92.5% had an uncorrected visual acuity of 20/40 or better. Patients averaged a
10.31-line improvement in UCVA, 61.6% of patients were within 0.5 D, and 84.7% were
within 1.0 D of predicted refraction. Only one case (0.2%) lost > 2 lines of BSCVA.
Gains of 2 or more lines of BSCVA occurred in 55 cases (11.8%) at 6 months and 41
cases (9.6%) at 1 year after ICL surgery. Early and largely asymptomatic, presumably
surgically induced anterior subcapsular (AS) opacities were seen in 11 cases (2.1%);
an additional early AS opacity (0.2%) was seen because of inadvertent anterior chamber
irrigation of preservative-containing solution at surgery. Two (0.4%) late (> or =
1 year postoperatively) AS opacities were observed. Two (0.4%) ICL removals with cataract
extraction and intraocular lens implantation have been performed. Patient satisfaction
(very/extremely satisfied) was reported by 92.4% of subjects on the subjective questionnaire;
only four patients (1.0%) reported dissatisfaction. Slightly more patients reported
an improvement at 1 year over baseline values for the following subjective symptoms:
quality of vision, glare, double vision, and night driving difficulties. Only a 3%
difference between pre-ICL and post-ICL surgery was reported for haloes.
The results support the safety, efficacy, and predictability of ICL implantation to
treat moderate to high myopia.