Prospective clinical study to evaluate efficacy of ICOLENS TM, a bifocal corneal implant to treat presbyopia

eoptics AG0 个研究点目标入组 30 人开始时间: 2010年6月24日最近更新: 2024年8月19日

适应症

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•Aged 45-65 years; no acute or chronic systemic disease (connective tissue disease as a consequence of immune deficiencies, uncontrolled diabetes, cancer); no serious, acute or chronic eye diseases (eg glaucoma, advanced cataract, retinopathy, macular degeneration and peripheral retinal disease); refraction ( objectively and subjectively) spherical equivalent of -0.5 diopters to +0.75 diopters at a maximum cylinder of -1.0; clearly identifiable dominant eye; round, refractive and pupil centered on non-dominant eye, which at 315 Lux a pupil diameter between 2.5mm and 4.6mm measured using a Procyon of Haag-Streit adduced; central corneal thickness in the non-dominant eye is 500-650 micrometers; respondent currently used reading glasses for activities in near distances and has an uncorrected near visual aquity of 0.4 logMAR in the non- dominant eye; normal, clear cornea and normal tears;. 2000 endothelial cells / qmm; no pathological changes in retina (macula and optic nerve); no clinically significant dry eye

•Volunteers who already had an eye operation; professional groups such as truck drivers, pilots and drivers; all other points, which are listed under inclusion criteria and do not apply

发起方

eoptics AG