Objective Assessment of Intraocular Lens Tilt and Decentration

NCT07324200•Johnson & Johnson Surgical Vision, Inc.

Summary

Prospective, multi-center, non-interventional, open label, randomized clinical study.

Detailed Description

The objective of this study is to evaluate the repeatability and reproducibility (R\&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
•2. Appear capable and willing to adhere to the clinical protocol instructions.
•3. Be 22 years of age or older at the time of screening.
•4. Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
•5. At least three months postoperative in the eligible eye.

Exclusion Criteria

•1. Any medical or ocular history, in the opinion of the investigator, that may impact study procedures such as ocular trauma, pseudoexfoliation syndrome, retinal pigment degeneration, macular pathology, glaucoma, retinal disease, corneal disease, or corneal opacities.
•2. Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
•3. Have a history of corneal or intraocular surgery other than cataract surgery.
•4. Using ocular or systemic medications known to interact with dilation drops.
•5. Have a history of allergic reactions to dilation drops.
•6. Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
•7. Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
•8. Have a mydriatic pupil diameter of less than 6 mm.
•9. Have participated in a clinical trial within 7 days prior to study enrollment.
•10. An employee (e.g., Investigator, Coordinator, or Technician) or immediate family member (including partner, child, parent, grandparent, grandchild, or sibling) of an employee of the clinical site or study sponsor.
+1 more criteria

Locations (2)

Empire Eye & Laser Center

Bakersfield, California, United States

Jones Eye Center

Sioux City, Iowa, United States

Key Dates

Start Date

March 3, 2026

Primary Completion Date

April 24, 2026

Completion Date

April 24, 2026

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Tilt and Decentration

Interventions

OCT Imaging Test

DIAGNOSTIC_TEST

Contacts

Siddhesh Raorane

CONTACT

904-539-7205 SRaorane@ITS.JNJ.com

Kristen Leraas

CONTACT

KLeraas@ITS.JNJ.com

Comparison of Methods for Assessing Intraocular Lens Position

NCT07218419

Tilt and Decentration

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: March 16, 2026Data 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.

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