Status:
COMPLETED
Visual Outcomes of Vivity in Patients With High Axial Length
Lead Sponsor:
Dr. James J. Wiens Medical Corporation
Collaborating Sponsors:
Sengi
Conditions:
Cataract
Eligibility:
All Genders
50+ years
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), a...
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 axia...
Eligibility Criteria
Inclusion
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Undergoing uncomplicated bilateral cataract surgery with IOL implantation.
- Gender: Males and Females.
- Age: 50 years 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.
- Motivated for greater degree of spectacle independence vs monofocal IOL.
- Axial length ≥24.5mm in both eyes.
- Planned cataract removal by femtosecond laser.
Exclusion
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Ocular comorbidity that might hamper postoperative visual acuity.
- Previous refractive surgery.
- Irregular corneal astigmatism.
- Evidence of keratoconus as per Pentacam.
- Expected post-op VA worse than 20/25 (Snellen).
- Refractive lens exchange.
- Difficulties comprehending written or spoken English language.
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease; unable to fixate).
- Clinically significant or severe ocular surface disease that would affect study measurements based on the investigator's opinion.
- Axial length \<24.5mm.
- 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.
Key Trial Info
Start Date :
January 13 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 6 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05210569
Start Date
January 13 2022
End Date
September 6 2023
Last Update
March 11 2025
Active Locations (1)
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1
Image Plus Laser Eye Centre
Winnipeg, Manitoba, Canada, R3C4K5