Clinical Investigation of Two Tecnis Investigational Lenses (NCT04890249) | Clinical Trial Compass
CompletedNot Applicable
Clinical Investigation of Two Tecnis Investigational Lenses
Australia221 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 Eyhanceâ„¢ 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 range22 Years
SexALL
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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…