Objective Assessment of Intraocular Lens Tilt and Decentration

NCT07324200 | Recruiting FDA Device

• 1 other identifier: MDEV113OCTI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tilt and Decentration

Outcome Measures

Primary Outcomes (1)

• Magnitude and Direction of IOL decentration and; Magnitude and Direction of IOL tilt.

  The primary endpoints for this study will be: * Magnitude of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL decentration relative to the visual axis through OCT (IOL Master 700) image analysis. * Magnitude of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis. * Direction of IOL tilt relative to the visual axis through OCT (IOL Master 700) image analysis.

  One study visit

Study Arms (2)

TECNIS refractive non-toric IOL models

The primary 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 non-toric IOL models.

Diagnostic Test: OCT Imaging Test

TECNIS diffractive non-toric IOL models

The primary 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 diffractive non-toric IOL models.

Interventions

OCT Imaging Test DIAGNOSTIC_TEST

The primary 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.

Also known as: Basic Science

TECNIS refractive non-toric IOL models

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As only one eye per subject will be enrolled in the study based on the eligibility criteria, up to approximately 80 subjects (40 by site) will be enrolled to obtain data on approximately 72 subjects (36 per site) to account for approximately 10% screen failure rate. All efforts will be made to enroll approximately 36 subjects per pre-study IOL group (i.e. 18 per site per pre-study IOL type). Approximately in total 36 subjects (18 per site) will be examined for each of the following two pre-study IOL groups. * Group 1: TECNIS refractive non-toric IOL models * Group 2: TECNIS diffractive non-toric IOL models

You may qualify if:

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

You may not qualify if:

• 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.
• Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
• Have a history of corneal or intraocular surgery other than cataract surgery.
• Using ocular or systemic medications known to interact with dilation drops.
• Have a history of allergic reactions to dilation drops.
• Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
• Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
• Have a mydriatic pupil diameter of less than 6 mm.
• Have participated in a clinical trial within 7 days prior to study enrollment.
• 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.
• Currently pregnant or lactating.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (2)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

RECRUITING

Jones Eye Center

Sioux City, Iowa, 51104, United States

RECRUITING

Study Officials

• Surgical Vision Inc. Johnson and Johnson

  Sponsor GmbH

  STUDY DIRECTOR

Central Study Contacts

Siddhesh Raorane

CONTACT

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

Kristen Leraas

CONTACT

KLeraas@ITS.JNJ.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 7, 2026
• Study Start: March 3, 2026
• Primary Completion: April 24, 2026
• Study Completion: April 24, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)