Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V

Cataracts Clinical Trial

Official title:

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens, Model DEN00V

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05574959
• Other study ID #: PCOL107AHNG
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: November 9, 2024

Study information

• Verified date: April 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, bilateral, masked (sponsor, subject and evaluator), randomized clinical trial to evaluate the safety and effectiveness of the TECNIS IOL, Model DEN00V in comparison to an aspheric monofocal IOL.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: November 9, 2024
• Est. primary completion date: November 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Minimum 22 years of age;

2. Bilateral cataracts for which posterior chamber IOL implantation has been planned;

3. Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source;

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

5. Corneal astigmatism:

1. Normal corneal topography;

2. = 1.0 D of preoperative keratometric astigmatism;

6. Clear intraocular media other than cataract;

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

8. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;

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

Exclusion Criteria:

1. Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D;

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

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

4. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.);

5. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;

6. Irregular corneal astigmatism;

7. Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures);

8. History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs;

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

10. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study;

11. 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;

12. Use of systemic or ocular medications that may affect vision;

13. Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);

14. Poorly controlled diabetes;

15. 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 outcomes 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;

16. Known ocular disease or pathology that, in the opinion of the investigator:

1. may affect visual acuity;

2. may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.);

3. may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.);

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

18. Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial;

19. Desire for monovision correction.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• investigational IOL Model DEN00V
Eligible subjects will be randomized in a 1:1 ratio to receive the investigational IOL Model DEN00V in both eyes for the duration of the study.
• control IOL Model ZCB00/DCB00
Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model ZCB00/DCB00 in both eyes for the duration of the study.

Locations

Country	Name	City	State
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	OCLI Vision	Garden City	New York
United States	Whitsett Vision Group	Houston	Texas
United States	Southern California Eye Physicians and Associates	Long Beach	California
United States	Carolina EyeCare Physicians, LLC	Mount Pleasant	South Carolina
United States	Focal Point Vision	San Antonio	Texas
United States	Parkhurst NuVision	San Antonio	Texas
United States	Jones Eye Center	Sioux City	Iowa
United States	Wolstan & Goldberg Eye Associates	Torrance	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	MONOCULAR PHOTOPIC DCIVA AT 66 CM	Mean (logMAR) monocular DCIVA under photopic conditions at 66 cm for first eyes in the investigational vs. control lens groups.	at 6-month follow-up
Primary	MONOCULAR PHOTOPIC BCDVA AT 4 M	Mean (logMAR) monocular BCDVA under photopic conditions at 4 meters for first eyes in the investigational vs. control lens groups.	at 6-month follow-up
Primary	Secondary Surgical Interventions (SSIs)	The rate of Secondary Surgical Interventions (SSIs) related to optical properties of the lens in eyes of subjects in the investigational lens group	at 6-month follow-up