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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00763360
Eligibility Criteria:
Inclusion Criteria:
* Patients able to understand and sign a document of informed consent;
* Patients aged ≥49 years with age-related cataract formation;
* Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
* Patients that have healthy eyes excluding the formation of cataract.
Exclusion Criteria:
* pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
* A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
* Iris atrophy in the operative eye;
* Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
* Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
* Ocular hypertension (lntraocular Pressure (IOP) \> 21 mmHg) in the operative eye at the baseline exam;
* Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
* Baseline endothelial cell density \< 1500 cells/mm2, in the operative eye;
* Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
* Patients 48 years of age or younger;
* Proliferative diabetic retinopathy in the operative eye;
* Uncontrolled diabetes mellitus;
* Marfan's Syndrome;
* An ocular disease and/or condition that may compromise results;
* A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
* Lens for the correction of astigmatism may be performed;
* Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
* A non-functional fellow eye;
* Participation in any other clinical study within the 30 days before surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
49 Years
Study:
NCT00763360
Study Brief:
Protocol Section:
NCT00763360