Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT00759668
Eligibility Criteria:
Inclusion:
* Written informed consent
* Age: ≥ 50 years ≤ 75 years
* Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)
* Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings
* Potential post operative Visual Acuity (VA) ≥ 20/40
* Second eye surgery to take place no longer than 45 days after the first implant
Exclusion:
* Irregular optical aberrations;
* Pupil diameter in scotopic conditions more than 6 mm
* Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))
* Other exclusions as from ReSTOR Directions for Use (DFU)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT00759668
Study Brief:
Protocol Section:
NCT00759668