Evaluation of the Rotational Stability of the Tecnis Toric II IOL

Cataract Clinical Trial

— STEELE  

Official title:

Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327518
• Other study ID #: NXGT-202-QROS
• Status: Completed
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2022
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 1, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Minimum 22 years of age;

2. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;

3. Pre-existing corneal astigmatism of one diopter or greater;

4. Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be =0.50 D;

5. Potential for postoperative BCDVA of 20/30 Snellen or better;

6. Clear intraocular media other than cataract in each eye;

7. Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;

8. Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;

9. Ability to understand and respond to a questionnaire in English.

Exclusion Criteria:

1. Irregular corneal astigmatism;

2. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;

3. Previous corneal or intraocular surgery;

4. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);

5. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);

6. Dilated pupil size of < 6.0 mm;

7. Recurrent severe anterior or posterior segment inflammation or uveitis;

8. 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;

9. Known ocular or systemic disease 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.];

10. Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);

11. Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes;

12. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

13. Planned monovision correction (eye designated for near correction)

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism

Intervention

Device:
• TECNIS® Toric II
Toric Intraocular Lens

Locations

Country	Name	City	State
United States	Empire Eye and Laser Center, Inc.	Bakersfield	California
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	JW Eye Associates, P.A. DBA Key-Whitman Eye Center	Dallas	Texas
United States	Texas Eye & Laser Center, P.A.	Hurst	Texas
United States	University of California	Los Angeles	California
United States	Jones Eye Clinic	Sioux City	Iowa
United States	Vance Thompson Vision, ND	W. Fargo	North Dakota

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	Percentage of Eyes With = 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit	Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.	1 week postoperative