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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01193504
Eligibility Criteria:
Inclusion Criteria:
* Male or female \>18 years of age scheduled to undergo cataract surgery
* Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
* Expected visual outcome of BCVA (best corrected visual acuity)\> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and OCT (optical coherence tomography).
* Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
Exclusion Criteria:
* Known contraindication to any study medication or any of their components
* Required use of ocular medications other than the study medications during the study
* Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome, macular hole) on preoperative OCT (optical coherence tomography)
* Presence of significant dry macular degeneration that may impact postoperative visual results.
* History of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation.
* Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
* Anticipated need for mechanical iris dilating devices
* Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact BCVA (best corrected visual acuity) postoperatively
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01193504
Study Brief:
Protocol Section:
NCT01193504