STEELE: Evaluation of the Rotational Stability of the Tecnis Toric II IOL

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04327518
Collaborator
(none)
125
Enrollment
7
Locations
1
Arm
11.7
Actual Duration (Months)
17.9
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: TECNIS® Toric II
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
Actual Study Start Date :
Jun 11, 2020
Actual Primary Completion Date :
Apr 6, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: TECNIS® Toric II

Subjects will be implanted in one or both eyes with the study lens

Device: TECNIS® Toric II
Toric Intraocular Lens

Outcome Measures

Primary Outcome Measures

  1. Percentage of eyes with ≤ 5º axis misalignment from the intended IOL axis of orientation [1 week Postoperative]

    Rotational stability of the IOL will be evaluated by measuring axis misalignment

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Empire Eye and Laser Center, Inc.BakersfieldCaliforniaUnited States93309
2University of CaliforniaLos AngelesCaliforniaUnited States92705
3Jones Eye ClinicSioux CityIowaUnited States51104
4Vance Thompson Vision, NDW. FargoNorth DakotaUnited States58078
5Cincinnati Eye InstituteCincinnatiOhioUnited States45242
6JW Eye Associates, P.A. DBA Key-Whitman Eye CenterDallasTexasUnited States75243
7Texas Eye & Laser Center, P.A.HurstTexasUnited States76054

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04327518
Other Study ID Numbers:
  • NXGT-202-QROS
First Posted:
Mar 31, 2020
Last Update Posted:
Jun 21, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2021