Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Johnson & Johnson Surgical Vision, Inc.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
