Clinical trial NCT04210232: Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
Official title: Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Corneal Astigmatism
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-24
Enrollment: 54
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.


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.

Primary outcomes:
measure: Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
timeFrame: 3 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: Annapolis
country: United States
facility: Chesapeake Eye Care and Laser Center
state: Maryland
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Birmingham
country: United States
facility: Oakland Ophthalmic Surgery, P.C.
state: Michigan
city: Saint Louis
country: United States
facility: Tekwani Vision Center
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Ladson
country: United States
facility: Carolina Cataract & Laser Center
state: South Carolina
city: Dallas
country: United States
facility: Key & Whitman Eye Center
state: Texas
city: Hurst
country: United States
facility: Texas Eye and Laser Center
state: Texas
city: San Antonio
country: United States
facility: Parkhurst NuVision
state: Texas
city: Lacey
country: United States
facility: Clarus Eye Center
state: Washington
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: