Objective Assessment of Intraocular Lens Tilt and Decentration

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

Study Overview

• Status: Recruiting
• Conditions: Tilt and Decentration
• Intervention / Treatment: Diagnostic test: OCT Imaging Test

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Kristen Leraas; Email: KLeraas@ITS.JNJ.com
• Study Contact Backup: Name: Siddhesh Raorane; Phone Number: 904-539-7205; Email: SRaorane@ITS.JNJ.com

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Recruiting
      • Empire Eye & Laser Center
      • Contact: Daniel Chang; Phone Number: 661-325-3937
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Recruiting
      • Jones Eye Center
      • Contact: Jason Jones; Phone Number: 712-239-3937

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

INCLUSION CRITERIA (ALL CRITERIA APPLY TO STUDY EYE)

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 (ALL CRITERIA APPLY TO STUDY EYE)

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.
11. Currently pregnant or lactating.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: Basic Science
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Surgical Vision Inc. Johnson and Johnson, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2026
• Primary Completion (Estimated): June 26, 2026
• Study Completion (Estimated): June 26, 2026

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MDEV113OCTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No