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 @ 5:30 PM
Ignite Modification Date:
2025-12-24 @ 5:30 PM
NCT ID:
NCT01290068
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to understand and sign an Informed Consent;
* Willing and able to attend post-operative examinations as per protocol schedule;
* Diagnosis of bilateral, age-related cataracts;
* Planned cataract removal via phacoemulsification with implantation of an IOL;
* Available to undergo second eye surgery within 6 weeks of the first eye surgery;
* Fulfill the recommendations of the "Warnings" and "Precautions" sections of the AcrySof IQ ReSTOR IOL and Monofocal IOL package inserts;
* No preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5D;
* Qualify in both eyes for either AcrySof® IQ ReSTOR® IOL Model SN6AD1 or AcrySof® IQ ReSTOR® Toric IOL Models SND1T2 through SND1T5 as indicated by the AcrySof IQ ReSTOR Multifocal Toric web-based calculator;
* Able to read and understand one of the following languages: Dutch, French, German, Italian, Spanish, English or Catalan.
* Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Previous corneal surgery and/or reshaping;
* Any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric IOL;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study;
* Pregnant, lactating, or planning pregnancy during the course of study;
* Other protocol-defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01290068
Study Brief:
Protocol Section:
NCT01290068