H52.4
Conditions
Interventions
Group 1: Contribution of the Icolens TM into the cornea.
Sponsors
Neoptics AG
Eligibility
Sex/Gender
All
Age
45 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Significant improvement after the introduction of the near visual acuity of the Icolens TM measured by the "Freiburg Visual Acuity Test" at 33 cm and an illumination of 315 lux compared to the near visual acuity before operation.It will be measured preoperative and 1 week, 1 month, 3 months, 6 months, 12 months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant improvement of the (binocular) measured reading ability compared with the situation before the intervention with the "Radner Reading Test" at 315 lux ambient lighting. Measured preoperative, 1 month, 6 months, 12 months after surgery. Impact of the introduction of the binocular Icolens TM visual acuity for the distance significantly lower than 1.5 logMAR steps with the "Freiburg Visual Acuity test measured" at 600cm and a room illumination of 315 lux. Measured preoperative, 1 week, 1 month, 3 months, 6 months, 12 months after surgery | — |
Countries
Germany
Contacts
Public ContactKatarina Pfeiffer
Klinik für Augenheilkunde, Goethe- Universität Frankfurt am Main
Outcome results
None listed