Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Vivity Extended Depth of Focus intraocular lens (IOL)

• Registration Number: NCT04482439
• Lead Sponsor: Newsom Eye & Laser Center

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.

Study Timeline

• Study Start: 2020-07-17
• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-22
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Status Verified: 2022-01
• Results First Submitted: 2022-01-17
• Results First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vivity mini-monovision	Vivity Extended Depth of Focus intraocular lens (IOL)	Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.

Primary Outcome Measures

Name	Time	Method
Binocular Near Visual Acuity	3 months postop	binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.

Secondary Outcome Measures

Name	Time	Method
Prediction Accuracy	3 months postop	Percentage of eyes with postoperative refractive accuracy within 0.5D of target
Spectacle Independence	3 months postop	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")
Patient Spectacle Independence	3 months postop	Patients reporting rarely or never needing glasses overall
Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"	3 months postop	This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.
Manifest Refraction	3 months postop	Manifest refraction (residual spherical equivalent refraction)
Residual Cylinder	3 months	Residual refractive cylinder after surgery
Uncorrected Distance Visual Acuity	3 months postop	Bilateral uncorrected distance visual acuity
Uncorrected Intermediate Visual Acuity	3 months postop	Bilateral uncorrected visual acuity at 66 cm
Uncorrected Near Visual Acuity	3 months postop	Bilateral uncorrected near visual acuity at 40 cm
Corrected Distance Visual Acuity	3 months postop	Bliateral corrected distance visual acuity
Distance Corrected Intermediate Visual Acuity	3 months postop	Bliateral distance corrected visual acuity at 66 cm

Trial Locations

Locations (1)

Newsom Eye and Laser Center; 🇺🇸 Sebring, Florida, United States