Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Cataracts Clinical Trial

Official title:

Clinical Investigation of the TECNIS® Next-Generation Intraocular Lens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06377514
• Other study ID #: PCOL109PHNG
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: Study Contact
• Phone: +1 832 2916944
• Email: klee161[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

INCLUSION CRITERIA

To be considered for enrollment in this study, patient must:

• be at least 22 years old

• have cataracts in both eyes

• sign the written informed consent

• be willing and able to comply with examination procedures

• understand, read and write English to complete informed consent and questionnaires

• be available for study follow-up visits EXCLUSION CRITERIA

Patient will not be eligible to take part in the study if:

• currently participating in any other clinical study or have participated in a clinical study during the last 30 days

• have a certain disease/illness, such as poorly controlled diabetes

• have certain ocular conditions, such as uncontrolled pressure in the eye

• taking medication that may affect vision

• pregnant, plan to become pregnant during the study, or are breastfeeding

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• Test IOL Model DEN00V
Eligible subjects will be randomized in a 1:1 ratio to receive the Test IOL Model DEN00V in both eyes for the duration of the study
• Control IOL Model DCB00
Eligible subjects will be randomized in a 1:1 ratio to receive the control IOL Model 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	Cleveland Eye Clinic	Brecksville	Ohio
United States	OCLI Vision	Garden City	New York
United States	Berkeley Eye Center	Houston	Texas
United States	Whitsett Vision Group	Houston	Texas
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Harvard Eye Associates	Laguna Hills	California
United States	Parkhurst NuVision	San Antonio	Texas
United States	Jones Eye Center	Sioux City	Iowa
United States	Vance Thompson Vision	Sioux Falls	South 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	Monocular photopic DCIVA (first eyes) at 66 cm	Mean DCIVA (logMAR) in test lens group is statistically significantly better (smaller) than in the control lens group	6 months
Primary	Monocular Depth of Focus	Monocular depth of defocus where visual acuity is 0.20 logMAR or better (measured only negative direction from zero) for first eyes at 6 months	6 months
Primary	Monocular Photopic BCDVA at 4m	Monocular photopic BCDVA at 4 meters for first eyes at 6 months	6 months
Primary	Monocular Photopic DCVA at 100 cm	Monocular photopic DCVA at 100 cm for first eyes at 6 months	6 months
Secondary	Monocular photopic DCNVA at 40 cm (first eyes)	Mean DCNVA (logMAR) in the test lens group is statistically significantly better (smaller) than in the control lens group	6 months