Clinical trial NCT04482439: Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye
Official title: Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Newsom Eye & Laser Center
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, 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), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

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).

Primary outcomes:
measure: Binocular Near Visual Acuity
timeFrame: 3 months postop
Secondary outcomes:
measure: Prediction Accuracy
timeFrame: 3 months postop
measure: Spectacle Independence
timeFrame: 3 months postop
measure: Patient Spectacle Independence
timeFrame: 3 months postop
measure: Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
timeFrame: 3 months postop
measure: Manifest Refraction
timeFrame: 3 months postop
measure: Residual Cylinder
timeFrame: 3 months
measure: Uncorrected Distance Visual Acuity
timeFrame: 3 months postop
measure: Uncorrected Intermediate Visual Acuity
timeFrame: 3 months postop
measure: Uncorrected Near Visual Acuity
timeFrame: 3 months postop
measure: Corrected Distance Visual Acuity
timeFrame: 3 months postop
measure: Distance Corrected Intermediate Visual Acuity
timeFrame: 3 months postop
Other outcomes:
Locations:
city: Sebring
country: United States
facility: Newsom Eye and Laser Center
state: Florida
Study officials:
affiliation: Newsom Eye & Laser Center
name: Thomas Newsom, MD
role: PRINCIPAL_INVESTIGATOR
References: