Comparison of Methods for Assessing Intraocular Lens Position

NCT07218419 | Completed FDA Device

• 1 other identifier: MDEV109TDMD
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tilt and Decentration

Outcome Measures

Primary Outcomes (1)

• IOL Decentration

  * Magnitude of Decentration relative to the center of the pupil. * Direction of Decentration relative to the center of the pupil

  3 months

Study Arms (1)

IOL Decentration

The objective is to evaluate two methods for assessing IOL tilt and decentration in patients who have been unilaterally or bilaterally implanted with a refractive or diffractive non- toric TECNIS IOL before participating into this study. The agreement will be assessed between the decentration measurements derived from retro-illuminated slit lamp image analysis and those obtained from the subjective slit lamp grading method.

Diagnostic Test: IOL Decentration Assessment

Interventions

IOL Decentration Assessment DIAGNOSTIC_TEST

This study assesses two methods to measure IOL decentration. Each subject will be evaluated in only one eye with both methods for assessing IOL decentration: (i) retro-illuminated slit lamp image analysis (objective slit lamp method) and (ii) subjective slit lamp grading method. There is no treatment or intervention on this study.

Also known as: Basic Science

IOL Decentration

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

Participants eligible for the study must be 22 years of age or older and have received a refractive or diffractive nontoric TECNIS IOL in at least one eye. Additionally, they must be at least three months post-operative in the designated study eye. The Investigator should choose the eye without any clinically significant medical conditions that may interfere with the evaluation of IOL tilt and decentration using the testing methods specified in this study. If both eyes meet the eligibility criteria, the right eye will be designated as the study eye.

You may qualify if:

• All criteria apply to study eye.
• The subject must:
• 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 procedures.
• Be 22 years of age or older at the time of screening.
• Have undergone unilateral or bilateral implantation with a desired TECNIS non-toric IOL design (e.g., refractive or diffractive).
• Be at least three months postoperative in the study eye.

You may not qualify if:

• All criteria apply to study eye.
• The subject must NOT:
• 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.
• Be using ocular or systemic medications known to interact with dilation drops.
• Have a history of hypersensitivity, allergic reaction or other contraindication to dilation drops.
• Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
• Have an intraocular pressure of ≥ 21mm Hg before mydriasis.
• Have a mydriatic pupil diameter of less than 6mm.
• Have participated in clinical trial within 7 days prior to study enrollment.
• Be 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.
• Be currently pregnant or lactating.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (2)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Jones Eye Center

Sioux City, Iowa, 51104, United States

Location

Study Officials

• Surgical Vision Inc. Johnson and Johnson

  Study Director

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 20, 2025
• Study Start: November 3, 2025
• Primary Completion: January 16, 2026
• Study Completion: January 16, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2)