A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.

Cataract Clinical Trial

Official title:

A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Eyhance™ Toric II Intraocular Lens With TECNIS Simplicity Delivery System, Model Series DIU and the TECNIS Synergy® Toric II Intraocular Lens With TECNIS Simplicity Delivery System, Model Series DFW to the TECNIS® Toric Intraocular Lens Model Series ZCT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05396599
• Other study ID #: JJSV201EYST
• Status: Terminated
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: April 7, 2023

Study information

• Verified date: April 2023
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: April 7, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum

study criteria in one or both eyes:

1. Male or female at least 22 years of age

2. Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens

3. Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s)

4. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits

5. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries. Exclusion Criteria: Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum

study criteria in one or both eyes:

1. Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR)

2. Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR)

3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs

4. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study

5. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) or unable to dilate to visualize IOL axis (approximately 6.0 mm)

6. Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures)

7. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject

8. Use of systemic or ocular medications that may affect vision

9. Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) 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)

10. Poorly controlled diabetes

11. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.

12. Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes

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

14. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Model DIU
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
• Model DFW
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
• Model ZCT
Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.

Locations

Country	Name	City	State
United States	Aloha Vision Consultants	Honolulu	Hawaii
United States	Shultz Chang Vision	Los Angeles	California
United States	Coastal Vision	Orange	California
United States	Parkhurst NuVision	San Antonio	Texas
United States	Pacific Eye Associates, A Medical Corporation	San Francisco	California

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	Rotational Stability of IOL	The percentage of eyes with rotational stability of the IOL at postoperative 6 months	6-months post-operative