U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia.
Ophthalmology
; 110(2): 255-66, 2003 Feb.
Article
en En
| MEDLINE
| ID: mdl-12578765
ABSTRACT
PURPOSE:
To assess the safety and efficacy of the Implantable Contact Lens (ICL) to treat moderate to high myopia.DESIGN:
Prospective nonrandomized clinical trial.PARTICIPANTS:
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. INTERVENTION Implantation of the ICL. MAIN OUTCOMEMEASURES:
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.RESULTS:
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.CONCLUSIONS:
The results support the safety, efficacy, and predictability of ICL implantation to treat moderate to high myopia.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Lentes de Contacto Hidrofílicos
/
Implantación de Prótesis
/
Cámara Anterior
/
Miopía
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
/
Observational_studies
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Prognostic_studies
/
Risk_factors_studies
Límite:
Adult
/
Female
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Humans
/
Male
/
Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Ophthalmology
Año:
2003
Tipo del documento:
Article
País de afiliación:
Estados Unidos