Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye
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 (IOL) when the non-dominant eye is targeted for slight myopia.
|Condition or Disease||Intervention/Treatment||Phase|
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 refraction.
Arms and Interventions
|Experimental: Vivity mini-monovision|
Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.
Device: Vivity Extended Depth of Focus intraocular lens (IOL)
Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
Primary Outcome Measures
- Binocular near visual acuity [3 months postop]
binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
Secondary Outcome Measures
- Prediction accuracy [1 and 3 months postop]
Percentage of eyes with postoperative refractive accuracy within 0.5D of target
- Spectacle independence [3 months postop]
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")
- Patient satisfaction [3 months postop]
Patient satisfaction questionnaire scores (IOLSAT proprietary questionnaire), based on a 0-4 scale, with lower being better.
- Visual disturbances [3 months postop]
Questionnaire for Visual Disturbance scores (QUVID proprietary questionnaire), based on a 0-4 scale with lower being better.
- Manifest refraction [1 and 3 months postop]
Manifest refraction (residual spherical equivalent refraction, residual sphere, and residual astigmatism)
- Uncorrected distance visual acuity [1 and 3 months postop]
Bilateral uncorrected distance visual acuity
- Uncorrected intermediate visual acuity [1 and 3 months postop]
Bilateral uncorrected visual acuity at 66 cm
- Uncorrected near visual acuity [1 and 3 months postop]
Bilateral uncorrected distance visual acuity at 40 cm
- Corrected distance visual acuity [1 and 3 months postop]
Bliateral corrected distance visual acuity
- Corrected intermediate visual acuity [1 and 3 months postop]
Bliateral corrected visual acuity at 66 cm
- Corrected near visual acuity [1 and 3 months postop]
Bliateral corrected visual acuity at 40 cm
• 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
• 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)
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).
Contacts and Locations
|1||Newsom Eye and Laser Center||Sebring||Florida||United States||33870|
Sponsors and Collaborators
- Newsom Eye & Laser Center
- Principal Investigator: Thomas Newsom, MD, Newsom Eye & Laser Center
Study Documents (Full-Text)None provided.