Comparison of Methods for Assessing Intraocular Lens Position
NCT ID: NCT07218419
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
55 participants
OBSERVATIONAL
2025-11-03
2026-01-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
IOL 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.
Interventions
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IOL 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
22 Years
ALL
Yes
Sponsors
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Johnson & Johnson Surgical Vision, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Surgical Vision Inc. Johnson and Johnson
Role: STUDY_DIRECTOR
Study Director
Locations
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Empire Eye & Laser Center
Bakersfield, California, United States
Jones Eye Center
Sioux City, Iowa, United States
Countries
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Central Contacts
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Other Identifiers
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MDEV109TDMD
Identifier Type: -
Identifier Source: org_study_id