Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Cataract Clinical Trial

— BRAVO  

Official title:

Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03949335
• Other study ID #: SUR-CAT-652-2001
• Status: Completed
• Phase: N/A
• Start date: July 31, 2019
• Est. completion date: June 18, 2020

Study information

• Verified date: August 2021
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization.

After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• 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:

• currently participating in any other clinical study or have participated in a clinical study during the last 60 days

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

• have certain ocular conditions such as uncontrolled glaucoma

• Is taking medication that may affect vision

• Subject is pregnant, plan to become pregnant during the study, or is breastfeeding

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Corneal Astigmatism

Intervention

Device:
• IOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V
• IOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00

Locations

Country	Name	City	State
United States	Chesapeake Eye Care & Laser Center	Annapolis	Maryland
United States	Empire Eye & Laser Center	Bakersfield	California
United States	Cincinnati Eye Institute	Blue Ash	Ohio
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Key-Whitman Eye Center	Dallas	Texas
United States	Berkeley Eye Institute	Houston	Texas
United States	Texas Eye and Laser Center	Hurst	Texas
United States	Clarus Eye Centre	Lacey	Washington
United States	Carolina EyeCare Physicians	Mount Pleasant	South Carolina
United States	Lehmann Eye Center	Nacogdoches	Texas
United States	Focal Point Vision	San Antonio	Texas
United States	Jones Eye Clinic	Sioux City	Iowa
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Wolstan & Goldberg Eye Associates	Torrance	California
United States	Katzen Eye Care & Laser Center	West Palm Beach	Florida

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	Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm	mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months	6 months (postoperative)
Secondary	Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm	mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population	6 months (postoperative)
Secondary	Monocular Distance-Corrected Near Visual Acuity at 33 cm	mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months	6 months postoperative
Secondary	Monocular Photopic Best-Corrected Distance Visual Acuity	mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.	6 months postoperative
Secondary	Monocular Distance-Corrected Defocus Curve	Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population	6 months postoperative
Secondary	Spectacle Wear	Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts "none of the time" in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.	6 months postoperative