Clinical trial NCT05488769: Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
Official title: Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cataract
Lead sponsor: Vision North Eye Centre
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2022-08-05
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be presenting for cataract surgery who are interested in a reduced dependence on spectacles for intermediate and distance vision, and who are considered appropriate candidates for EDOF lens implantation.

Brief summary: The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

Detailed description: This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity 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), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity 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.

* Visually significant age-related cataracts bilaterally.
* Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
* Gender: Males and Females.
* 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.
* Clear intraocular media other than cataract.
* Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
* IOL powers between 6D and 30D, T2-T6.

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Previous ocular or refractive surgery
* Ocular surface disease/Dry Eye Disease
* Intraoperative complications during procedure
* Glaucoma, including well-controlled
* Any disorders that reduce binocular vision (ie Strabismus)
* Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)

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 distance-corrected visual acuity at distance (6m)
timeFrame: 3 months postoperative
measure: Binocular distance-corrected visual acuity at intermediate (66cm)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Percentage of eyes with absolute prediction error less than or equal to 0.50D
timeFrame: 3 months postoperative
measure: Percentage of eyes with refractive astigmatism less than or equal to 0.50 D
timeFrame: 3 months postoperative
Other outcomes:
measure: Satisfaction questionnaire
timeFrame: 3 months postoperative
measure: Visual disturbances questionnaire
timeFrame: 3 months postoperative
measure: Binocular uncorrected and distance-corrected visual acuity at near (40cm)
timeFrame: 3 months postoperative
Locations:
city: Terrace
country: Canada
facility: Vision North Eye Centre
state: British Columbia
Study officials:
affiliation: Vision North Eye Centre
name: Thomas Nagy, MD
role: PRINCIPAL_INVESTIGATOR
References: