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 @ 4:22 PM
Ignite Modification Date:
2025-12-24 @ 4:22 PM
NCT ID:
NCT01384266
Eligibility Criteria:
Inclusion Criteria:
* Subjects age 18 and older undergoing routine cataract surgery.
Exclusion Criteria:
1. Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity.
2. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed.
3. Subjects with previous ocular trauma or intraocular surgery
4. Subjects with sensitivities to steroids.
5. Women who are not post-menopausal or are of child bearing potential will be excluded.
6. Intraoperative complications during surgery including posterior capsule rupture and vitreous loss
7. Subjects with best visual potential in the fellow eye worse than 20/60
8. Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted.
9. Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01384266
Study Brief:
Protocol Section:
NCT01384266