Clinical trial NCT04327518: Evaluation of the Rotational Stability of the Tecnis Toric II IOL
Official title: Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Corneal Astigmatism
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-31
Enrollment: 125
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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit
timeFrame: 1 week postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye and Laser Center, Inc.
state: California
city: Los Angeles
country: United States
facility: University of California
state: California
city: Sioux City
country: United States
facility: Jones Eye Clinic
state: Iowa
city: W. Fargo
country: United States
facility: Vance Thompson Vision, ND
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Dallas
country: United States
facility: JW Eye Associates, P.A. DBA Key-Whitman Eye Center
state: Texas
city: Hurst
country: United States
facility: Texas Eye & Laser Center, P.A.
state: Texas
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Johnson & Johnson Surgical Vision Clinical Trials
role: STUDY_DIRECTOR
References: