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NCT05090826 Clinical Trial

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

Cataracts Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05090826
Other study ID # PCOL-201-CHSN
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 28, 2021
Est. completion date April 30, 2024

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

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 42
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: 1. Male or female patients at least 22 years of age 2. 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 3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits 4. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian Exclusion Criteria: 1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit 2. Planned monovision correction (one eye designated for near correction). 3. 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.).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Model ZFR00V
Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.

Locations
Country Name City State
China Hainan Eye Optometry Eye Hospital Co., Ltd. No. 6 Qionghai Hainan

Sponsors (1)
Lead Sponsor Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean monocular postoperative DCNVA 6 months
Primary percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCNVA 6 months
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