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Comparison of Methods for Assessing Intraocular Lens Position

Comparison of Methods for Assessing Intraocular Lens Position

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07218419
Enrollment
53
Registered
2025-10-20
Start date
2025-11-03
Completion date
2026-01-16
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tilt and Decentration

Brief summary

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

Detailed description

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 nontoric 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.

Interventions

DIAGNOSTIC_TESTIOL Decentration Assessment

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.

Sponsors

Johnson & Johnson Surgical Vision, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Inclusion: 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. Exclusion: 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.

Design outcomes

Primary

MeasureTime frameDescription
IOL Decentration3 months* Magnitude of Decentration relative to the center of the pupil. * Direction of Decentration relative to the center of the pupil

Countries

United States

Contacts

STUDY_DIRECTORSurgical Vision Inc. Johnson and Johnson

Study Director

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026