Status:
RECRUITING
Comparison of Methods for Assessing Intraocular Lens Position
Lead Sponsor:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Tilt and Decentration
Eligibility:
All Genders
22+ years
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 be...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 14 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT07218419
Start Date
November 3 2025
End Date
January 14 2026
Last Update
December 18 2025
Active Locations (2)
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1
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
2
Jones Eye Center
Sioux City, Iowa, United States, 51104