N/A
Completed N=35
Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye
Source: ClinicalTrials.gov NCT04482439 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Binocular Near Visual Acuity — 0.14 logMAR
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 (IOL) when the non-dominant eye is targeted for slight myopia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binocular Near Visual Acuity |
0.14 | — |
| SECONDARY Prediction Accuracy |
56 | — |
| SECONDARY Spectacle Independence |
26 | — |
| SECONDARY Patient Spectacle Independence |
23 | — |
| SECONDARY Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" |
19; 18; 13 | — |
| SECONDARY Manifest Refraction |
.01; -.74 | — |
| SECONDARY Residual Cylinder |
0.42 | — |
| SECONDARY Uncorrected Distance Visual Acuity |
0.02 | — |
| SECONDARY Uncorrected Intermediate Visual Acuity |
— | — |
| SECONDARY Uncorrected Near Visual Acuity |
0.12 | — |
| SECONDARY Corrected Distance Visual Acuity |
0.01 | — |
| SECONDARY Distance Corrected Intermediate Visual Acuity |
0.02 | — |
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).
Data sourced from ClinicalTrials.gov (NCT04482439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.