Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

Launched by NEWSOM EYE & LASER CENTER · Jul 17, 2020

Keywords

ClinConnect Summary

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest ...

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Eligibility criteria

• Inclusion Criteria:
• • • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL
• • Meet the requirements for on-label implantation of the EDF IOL
• • Gender: Males and Females.
• • Age: 40 or older.
• • Willing and able to provide written informed consent for participation in the study.
• • Willing and able to comply with scheduled visits and other study procedures.
• • Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
• • Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL.
• • Have 20/32 (0.2 logMAR) or better potential acuity in both eyes
• Exclusion Criteria:
• • • Irregular astigmatism (e.g. keratoconus)
• • Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
• • Monocular status (e.g. amblyopia)
• • Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
• • Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
• • Diabetic retinopathy
• • Macular pathology (e.g. ARMD, ERM)
• • History of retinal detachment
• • Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
• • Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).