Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Launched by JOHNSON & JOHNSON SURGICAL VISION, INC. · Aug 26, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Minimum 22 years of age
• • Bilateral cataracts for which posterior chamber IOL implantation has been planned
• • Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
• • Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
• * Corneal astigmatism parameters:
• • Normal corneal topography and no irregular corneal astigmatism
• • Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
• • Clear intraocular media other than cataract in each eye
• • Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
• • Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• • Ability to understand and respond to a questionnaire in English
• Exclusion Criteria:
• • Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
• • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• • Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• • Desire for monovision correction