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

eoptics AG0 sites30 target enrollmentJune 24, 2010

Overview

No summary available.

Registry

who.int

Start Date

June 24, 2010

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

eoptics AG

•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