A Real-World Study for the TECNIS Synergy™ Intraocular Lens

Sponsor

Johnson & Johnson Surgical Vision, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05090826

Collaborator

(none)

100

Enrollment

Location

Arm

24.1

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Synergy™ IOL. The study will enroll up to 100 subjects from a single site in China. All implanted subjects will be followed for 12 months postoperatively.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: Model ZFR00V	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Real-World Study Evaluating Clinical Outcomes in China for the TECNIS Synergy™ Intraocular Lens Model ZFR00V

Actual Study Start Date :

Dec 28, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TECNIS Synergy IOL Model ZFR00V	Device: Model ZFR00V Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.

Arm

Intervention/Treatment

Experimental: TECNIS Synergy IOL

Model ZFR00V

Device: Model ZFR00V

Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.

Outcome Measures

Primary Outcome Measures

mean monocular postoperative DCNVA [6 months]
percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCNVA [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female patients at least 22 years of age
Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Synergy intraocular lens
Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian

Exclusion Criteria:

Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
Planned monovision correction (one eye designated for near correction).
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 course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6	Qionghai	Hainan	China	571434

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:

NCT05090826

Other Study ID Numbers:

PCOL-201-CHSN

First Posted:

Oct 25, 2021

Last Update Posted:

Aug 9, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Aug 9, 2022