Visual Outcomes of Vivity in Patients With High Axial Length
Study Details
Study Description
Brief Summary
The objective is to assess the visual outcomes and quality of vision of patients receiving the AcrySof® Vivity Intraocular lens (IOL), when implanted in eyes with high ocular axial length (≥24.5mm), after uneventful cataract surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This study is a single-arm unmasked clinical evaluation study of binocular uncorrected visual acuity at distance (6m), intermediate (66cm) and near (40cm), when implanted in eyes with high ocular axial length (≥24.5mm), after successful bilateral cataract surgery. Subjects will be assessed preoperatively, operatively, and at 1 day, 1 week, 1 month, and 3 months postoperatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID) and a satisfaction questionnaire (IOLSAT), as well as measurement of binocular and monocular visual acuities and manifest refraction.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Bilateral implantation of the Vivity IOL Vivity intraocular lens (IOL) |
Device: Vivity
Vivity intraocular lens (IOL)
|
Outcome Measures
Primary Outcome Measures
- Binocular uncorrected distance visual acuity [3 months]
Binocular uncorrected distance visual acuity
- Binocular uncorrected intermediate visual acuity [3 months]
Binocular uncorrected intermediate visual acuity
- Binocular uncorrected near visual acuity [3 months]
Binocular uncorrected near visual acuity
Secondary Outcome Measures
- Prediction error [3 months]
Percentage of eyes with absolute prediction error of 0.5D or less
- Binocular best-corrected distance visual acuity [3 months]
Binocular best-corrected distance visual acuity
- Binocular best-corrected intermediate visual acuity [3 months]
Binocular best-corrected intermediate visual acuity
- Binocular best-corrected near visual acuity [3 months]
Binocular best-corrected near visual acuity
- Monocular best-corrected distance visual acuity [3 months]
Monocular best-corrected distance visual acuity
- Monocular best-corrected intermediate visual acuity [3 months]
Monocular best-corrected intermediate visual acuity
- Monocular best-corrected near visual acuity [3 months]
Monocular best-corrected near visual acuity
- Manifest refraction [3 months]
Residual spherical equivalent refraction, residual sphere, and residual astigmatism
- Questionnaire [3 months]
Questionnaire for visual disturbance scores (QUVID)
- Questionnaire [3 months]
Patient satisfaction questionnaire scores (IOLSAT)
- Binocular distance-corrected low contrast distance visual acuity [3 months]
Binocular distance-corrected low contrast distance visual acuity
Eligibility Criteria
Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
Inclusion Criteria:
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Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
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Gender: Males and Females.
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Age: 50 years or older.
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Willing and able to provide written informed consent for participation in the study.
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Willing and able to comply with scheduled visits and other study procedures.
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Motivated for greater degree of spectacle independence vs monofocal IOL.
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Axial length ≥24.5mm in both eyes.
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Planned cataract removal by femtosecond laser.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
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Ocular comorbidity that might hamper postoperative visual acuity.
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Previous refractive surgery.
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Irregular corneal astigmatism.
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Evidence of keratoconus as per Pentacam.
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Expected post-op VA worse than 20/25 (Snellen).
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Refractive lens exchange.
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Difficulties comprehending written or spoken English language.
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Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
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Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
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Axial length <24.5mm.
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Evidence of macular pathology as per optical coherence tomography examination.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Image Plus Laser Eye Centre | Winnipeg | Manitoba | Canada | R3C4K5 |
Sponsors and Collaborators
- Dr. James J. Wiens Medical Corporation
- Sengi
Investigators
- Principal Investigator: James J Wiens, MD, Dr. James J. Wiens Medical Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JW-21-001