H26.9
Conditions
Interventions
Group 1: Collect and evaluate clinical data on safety and performance of actual registered and marketed HOYA Surgical Optics Nanex IOL within the duration of the study with 7 visits at different time
Sponsors
HOYA Surgical Optics GmbH
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult subjects with a minimum age of 22 years and planned for lens extraction (e.g. cataract, dysfunctional lens syndrome) and implantation of the study IOL and otherwise healthy eyes.
Exclusion criteria
Exclusion criteria: 1. Various eye diseases that could reduce visual acuity. 2. Study participant is pregnant, or planning to become pregnant or breastfeeding. 3. Concurrent participation or participation within 30 days in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - monocular best corrected distance visual acuity with reading chart - Incidence of adverse events All study endpoints will be evaluated at Form 4 (4-6-month postoperative) and Form 5 (11 to 14 months postoperative). | — |
Secondary
| Measure | Time frame |
|---|---|
| - UDVA at Form 4 with reading chart - Percentage of eyes with SEQ within ± 0.50 D and ± 1.00 D versus target with reading chart | — |
Countries
Germany, Philippines, Poland, Spain
Contacts
Public ContactMichael Bonilla
Hoya Surgical Optics, Inc.
Outcome results
None listed