Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

Cataract Clinical Trial

Official title:

Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210232
• Other study ID #: NXGT-201-TTL2
• Status: Completed
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: September 11, 2020

Study information

• Verified date: October 2021
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism

Intervention

Device:
• TECNIS® TORIC II Intraocular Lens (IOL)
Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.

Locations

Country	Name	City	State
United States	Chesapeake Eye Care and Laser Center	Annapolis	Maryland
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Oakland Ophthalmic Surgery, P.C.	Birmingham	Michigan
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Key & Whitman Eye Center	Dallas	Texas
United States	Texas Eye and Laser Center	Hurst	Texas
United States	Clarus Eye Center	Lacey	Washington
United States	Carolina Cataract & Laser Center	Ladson	South Carolina
United States	Tekwani Vision Center	Saint Louis	Missouri
United States	Parkhurst NuVision	San Antonio	Texas
United States	Jones Eye Clinic	Sioux City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II	Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).	3 months postoperative