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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04482439
• Other study ID #: TN-20-001
• Status: Completed
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: June 10, 2021

Study information

• Verified date: January 2022
• Source: Newsom Eye & Laser Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 10, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Vivity Extended Depth of Focus intraocular lens (IOL)
Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.

Locations

Country	Name	City	State
United States	Newsom Eye and Laser Center	Sebring	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Newsom Eye & Laser Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binocular Near Visual Acuity	binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.	3 months postop
Secondary	Prediction Accuracy	Percentage of eyes with postoperative refractive accuracy within 0.5D of target	3 months postop
Secondary	Spectacle Independence	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")	3 months postop
Secondary	Patient Spectacle Independence	Patients reporting rarely or never needing glasses overall	3 months postop
Secondary	Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"	This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.	3 months postop
Secondary	Manifest Refraction	Manifest refraction (residual spherical equivalent refraction)	3 months postop
Secondary	Residual Cylinder	Residual refractive cylinder after surgery	3 months
Secondary	Uncorrected Distance Visual Acuity	Bilateral uncorrected distance visual acuity	3 months postop
Secondary	Uncorrected Intermediate Visual Acuity	Bilateral uncorrected visual acuity at 66 cm	3 months postop
Secondary	Uncorrected Near Visual Acuity	Bilateral uncorrected near visual acuity at 40 cm	3 months postop
Secondary	Corrected Distance Visual Acuity	Bliateral corrected distance visual acuity	3 months postop
Secondary	Distance Corrected Intermediate Visual Acuity	Bliateral distance corrected visual acuity at 66 cm	3 months postop