Comparison of Methods for Assessing Intraocular Lens Position

Comparison of Methods for Assessing Intraocular Lens Position

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

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.

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.