Johnson & Johnson Surgical Vision, Inc.
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…
The primary 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.
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