Status:
COMPLETED
Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye
Lead Sponsor:
Newsom Eye & Laser Center
Conditions:
Cataract
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IO...
Detailed Description
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 bila...
Eligibility Criteria
Inclusion
- • 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
- • 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).
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04482439
Start Date
July 17 2020
End Date
June 10 2021
Last Update
March 3 2022
Active Locations (1)
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1
Newsom Eye and Laser Center
Sebring, Florida, United States, 33870