Clinical trial NCT05210569: Visual Outcomes of Vivity in Patients With High Axial Length
Official title: Visual Outcomes of the AcrySof® Vivity Intraocular Lens in Patients With High Ocular Axial Length
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: EDOF IOL Vivity
Lead sponsor: Dr. James J. Wiens Medical Corporation
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.

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.

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.

Eligibility criteria: Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

Inclusion Criteria:

* 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 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.

* 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.

Primary outcomes:
measure: Binocular Uncorrected Distance Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Binocular Uncorrected Intermediate Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Binocular Uncorrected Near Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Prediction Error
timeFrame: 3 months postoperatively
measure: Binocular Corrected Distance Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Binocular Distance Corrected Intermediate Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Binocular Distance Corrected Near Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Monocular Corrected Distance Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Monocular Distance Corrected Intermediate Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Monocular Distance Corrected Near Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
measure: Manifest Refraction Spherical Equivalent
timeFrame: 3 months postoperatively
measure: Questionnaire
timeFrame: 3 months postoperatively
measure: Percentage of Participants With Spectacle Independence
timeFrame: 3 months
measure: Binocular Distance-corrected Low Contrast Distance Visual Acuity (logMAR)
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Image Plus Laser Eye Centre
state: Manitoba
Study officials:
affiliation: Dr. James J. Wiens Medical Corporation
name: James J Wiens, MD
role: PRINCIPAL_INVESTIGATOR
References: