Objective Assessment of Intraocular Lens Tilt and Decentration

Objective Assessment of Intraocular Lens Tilt and Decentration

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

The objective of this study is to evaluate the repeatability and reproducibility (R&R) of a method based on Optical Coherence Tomography (OCT) image analysis for assessing IOL tilt and decentration in patients unilaterally or bilaterally implanted with TECNIS refractive or diffractive non-toric IOL models.

INCLUSION CRITERIA (ALL CRITERIA APPLY TO STUDY EYE)

1. Read, understand, and sign the informed consent and HIPAA authorization forms, and receive a fully executed copy of the signed forms.
2. Appear capable and willing to adhere to the clinical protocol instructions.
3. Be 22 years of age or older at the time of screening.
4. Have undergone unilateral or bilateral implantation with a desired non-toric TECNIS IOL design (e.g., refractive or diffractive).
5. At least three months postoperative in the eligible eye.

EXCLUSION CRITERIA (ALL CRITERIA APPLY TO STUDY EYE)

1. 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.
2. Have any condition that may affect the eye's ability to fixate (e.g., amblyopia).
3. Have a history of corneal or intraocular surgery other than cataract surgery.
4. Using ocular or systemic medications known to interact with dilation drops.
5. Have a history of allergic reactions to dilation drops.
6. Have clinically significant pupil abnormalities (e.g., non-reactive, fixed, or abnormally shaped pupils).
7. Has an intraocular pressure of ≥ 21mm Hg before mydriasis.
8. Have a mydriatic pupil diameter of less than 6 mm.
9. Have participated in a clinical trial within 7 days prior to study enrollment.
10. 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.
11. Currently pregnant or lactating.