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

NCT04482439 | Completed Results FDA Device

• 1 other identifier: TN-20-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Binocular Near Visual Acuity

  binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.

  3 months postop

Secondary Outcomes (11)

• Prediction Accuracy

  3 months postop

• Spectacle Independence

  3 months postop

• Patient Spectacle Independence

  3 months postop

• Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"

  3 months postop

• Manifest Refraction

  3 months postop

Study Arms (1)

Vivity mini-monovision

EXPERIMENTAL

Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.

Device: Vivity Extended Depth of Focus intraocular lens (IOL)

Interventions

Vivity Extended Depth of Focus intraocular lens (IOL) DEVICE

Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.

Vivity mini-monovision

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Newsom Eye & Laser Center: lead

Study Sites (1)

Newsom Eye and Laser Center

Sebring, Florida, 33870, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: T. Hunter Newsom, MD
• Organization: Newsom Eye and Laser Center

hunter@newsomeye.net

813-908-2020

Study Officials

• Thomas Newsom, MD

  Newsom Eye & Laser Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: July 17, 2020
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: March 3, 2022
• Results First Posted: March 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)