Clinical Investigation of Two Tecnis Investigational Lenses (NCT04890249) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of Two Tecnis Investigational Lenses
Australia, New Zealand221 participantsStarted 2021-06-23
Plain-language summary
This study is a 6-month, prospective, multicenter, randomized (1:1:1), subject-masked and evaluator-masked, bilateral clinical investigation of the TECNIS IOL Models C1V000 and C2V000 versus the TECNIS Eyhance™ Model ICB00 IOL.
The study will be conducted at up to 15 sites in EU, AU, NZ and/or AP and will enroll up to 225 subjects to achieve approximately 67 bilaterally implanted subjects in each lens group. Allowing for 10% lost-to-follow-up, this will achieve approximately 60 evaluable subjects in each lens group at 1, 3, and 6 months. The eye implanted first will be considered the primary (monocular) study eye.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Minimum 22 years of age
* Bilateral cataracts or planned natural lens removal (due to immature cataract) for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
* Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms in the opinion of the investigator
* Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better
* Corneal astigmatism:
* Normal corneal topography
* Predicted postoperative corneal astigmatism of less than 1.00 D in both eyes, including posterior corneal astigmatism (PCA)
* Clear intraocular media other than cataract
* Signed informed consent for participation in the study and data protection
* Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
* Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided.
Exclusion Criteria:
* Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D
* Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
* Inability to focus or fixate for prolonged periods o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.