Comparison of Methods for Assessing Intraocular Lens Position

Johnson & Johnson (J&J)

Status: Enrolling

Conditions: Tilt and Decentration

Treatments: Diagnostic Test: IOL Decentration Assessment

Study type: Observational

Funder types: Industry

Identifiers

NCT07218419

MDEV109TDMD

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

55 participants in 1 patient group

IOL Decentration

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 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.

Treatment:

Diagnostic Test: IOL Decentration Assessment