Loading clinical trials...

Clinical Investigation of the Next-Generation Intraocular Lens | Clinical Trials | Clareo Health

COMPLETEDNA

Clinical Investigation of the Next-Generation Intraocular Lens

Clinical Investigation of the TECNIS Next-Generation Intraocular Lens

NCT03111550•Abbott Medical Optics

Summary

This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL. The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Bilateral cataracts
•Potential for postoperative BCDVA of 20/30 Snellen or better
•Corneal astigmatism of 1.00 D or less in both eyes
•Normal corneal topography
•Clear intraocular media other than cataract in each eye
•Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries

Exclusion Criteria

•Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
•Irregular corneal astigmatism
•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
•Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
•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
•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
•Use of systemic or ocular medications that may affect vision
+7 more criteria

Locations (12)

Empire Eye and Laser Center

Bakersfield, California, United States

Assil Eye Institute

Beverly Hills, California, United States

Jones Eye Care

Sioux City, Iowa, United States

Chesapeake Eye Care and Laser

Annapolis, Maryland, United States

Eye Doctors of Washington

Chevy Chase, Maryland, United States

Ophthalmology Consultants LTD

St Louis, Missouri, United States

Scott and Christie and Associates,PC

Cranberry Township, Pennsylvania, United States

Carolina Cataract and Laser Center

Ladson, South Carolina, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Loden Vision Centers

Goodlettsville, Tennessee, United States

Key Dates

Start Date

May 10, 2017

Primary Completion Date

February 23, 2018

Completion Date

February 23, 2018

Last Updated

June 24, 2025

Enrollment

242

ACTUAL participants

Conditions

Cataract

Interventions

Investigational Intraocular Lens Device #1: TECNIS Model ZHR00

DEVICE

Investigational Intraocular Lens Device #2: TECNIS Model ZQR00

DEVICE

TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00

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

View study

RECRUITING

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

NCT07362043

Cataract Surgery

View study

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: June 24, 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.

View ClinicalTrials.gov Terms and Conditions

Clinical Investigation of the Next-Generation Intraocular Lens

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