Clinical Investigation of the Safety and Effectiveness of an Investigational Model of the TECNIS® Intraocular Lens
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Enrollment
- 272
- Locations
- 15
- Primary Endpoint
- Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
Time Frame: 6 months (postoperative)
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
Secondary Outcomes
- Monocular Distance-Corrected Defocus Curve(6 months postoperative)
- Spectacle Wear(6 months postoperative)
- Monocular Distance-Corrected Near Visual Acuity at 33 cm(6 months postoperative)
- Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm(6 months (postoperative))
- Monocular Photopic Best-Corrected Distance Visual Acuity(6 months postoperative)