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Clinical Investigation of Two Tecnis Investigational Lenses | Clinical Trials | Clareo Health

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Clinical Investigation of Two Tecnis Investigational Lenses

Clinical Investigation of the TECNIS® Intraocular Lens, Models C1V000 and C2V000

NCT04890249•Johnson & Johnson Surgical Vision, Inc.

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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 of time (e.g., due to strabismus, nystagmus, etc.)
•Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
•Corneal abnormalities such as stromal, epithelial, or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study
•Irregular corneal astigmatism
•Inability to achieve keratometric stability for contact lens wearers
•Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
•Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study
•Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
+11 more criteria

Locations (8)

personalEYES Pty. Ltd.

Burwood, New South Wales, Australia

Vision Eye Institute

Chatswood, New South Wales, Australia

George St Eye Centre

Sydney, New South Wales, Australia

Bondi Eye Doctors

Sydney, New South Wales, Australia

Newcastle Eye Hospital

Waratah, New South Wales, Australia

Sunshine Eye Clinic

Birtinya, Queensland, Australia

Queensland Eye Institute

South Brisbane, Queensland, Australia

Auckland Eye Ltd

Remuera, Auckland, New Zealand

Key Dates

Start Date

June 23, 2021

Primary Completion Date

January 31, 2023

Completion Date

January 31, 2023

Last Updated

May 23, 2025

Enrollment

221

ACTUAL participants

Conditions

CataractCorneal Astigmatism

Interventions

Investigational IOL Model C1V000

DEVICE

Investigational IOL Model C2V000

DEVICE

Control IOL Model ICB00

DEVICE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Investigation of Two Tecnis Investigational Lenses

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery