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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT04210232
Eligibility Criteria:
Inclusion Criteria:
1. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
2. Preoperative corneal astigmatism of one diopter or more in the operative eye;
3. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
4. Clear intraocular media other than cataract in each eye;
5. Ability to understand, read and write English in order to consent to study participation;
6. Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
7. Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Exclusion Criteria:
1. Recurrent severe anterior or posterior segment inflammation or uveitis;
2. Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
3. Circumstances that would result in damage to the endothelium during implantation;
4. Suspected ocular microbial infection;
5. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;
6. Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, \[macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.\];
7. Planned monovision correction;
8. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04210232
Study Brief:
Protocol Section:
NCT04210232