Cataracts
Conditions
Brief summary
This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All subjects will be followed for 12 months postoperatively.
Interventions
DEVICEModel ICB00
Investigational intraocular lens replaces the natural lens removed during cataract surgery in one or both eyes.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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 Eyhance 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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean monocular postoperative DCIVA | 6 months |
| percentage of eyes that achieve 0.3 ,0.2, 0.1 and 0.0 logMAR monocular DCIVA | 6 months |
Countries
China
Outcome results
None listed