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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT00760058
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects, aged 50 and over.
* Subjects diagnosed with bilateral cataracts requiring cataract extraction and implantation of a posterior chamber intraocular lens.
* Subjects must be willing to undertake the additional ophthalmic tests within 3 months of the second lens implantation.
* Subjects must be assessed to be able to dilate to a minimum of 6 mm pre operatively.
* Subjects' pupil size must be ≥ 4.5 mm in mesopic conditions.
Exclusion Criteria:
* Subjects who have previously had corneal surgery.
* Subjects who have potential visual acuity which is \< 6/12 due to other ocular pathology
* Subjects with corneal pathology.
* Subjects with astigmatism of greater than 1D.
* Subjects diagnosed with glaucoma.
* Subjects diagnosed with diabetes.
* Subjects who have previously participated in a clinical investigation within 30 days prior to enrolment
* Subjects with a know history of poor compliance
* Subjects with planned adjunctive surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00760058
Study Brief:
Protocol Section:
NCT00760058