Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens

NCT ID: NCT07070492

Last Updated: 2025-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2027-07-31

Brief Summary

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To investigate the patient Quality of Life and satisfaction outcomes of combined cataract surgery with retinal surgery for visually significant epiretinal membrane in patients receiving Vivity IOL versus standard monofocal controls.

Detailed Description

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The information gained by this study will help understand better the suitability of Vivity IOLs for patients with a common retinal condition and potentially expand access and offering of premium IOLs to help patients gain independence from glasses, which can improve quality of life.

Conditions

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Cataract and IOL Surgery Epi-retinal Membrane

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vivity Extended Depth of Focus IOL

Group Type EXPERIMENTAL

cataract surgery

Intervention Type DEVICE

cataract surgery receiving Vivity IOL or standard mono focal controls

retinal surgery

Intervention Type PROCEDURE

Retinal surgery for visually significant epiretinal membrane

Standard monofocal IOL

Group Type ACTIVE_COMPARATOR

cataract surgery

Intervention Type DEVICE

cataract surgery receiving Vivity IOL or standard mono focal controls

retinal surgery

Intervention Type PROCEDURE

Retinal surgery for visually significant epiretinal membrane

Interventions

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cataract surgery

cataract surgery receiving Vivity IOL or standard mono focal controls

Intervention Type DEVICE

retinal surgery

Retinal surgery for visually significant epiretinal membrane

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patients with visually significant epiretinal membrane who are undergoing or have already had pars plana vitrectomy and membrane peel combined with cataract surgery using Clareon Vivity and Clareon Vivity Toric IOLs or monofocal IOL
* IOL powers between +6D to +30.0D, T3-T6

Exclusion Criteria

* History of ocular or refractive surgery
* Other ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity, such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc.
* Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity
* Intraoperative or postoperative complications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Debbie Kuo, MD

OTHER

Sponsor Role lead

Responsible Party

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Debbie Kuo, MD

Palo Alto Foundation Medical Group affiliated Ophthalmologist

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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2025.067-1

Identifier Type: -

Identifier Source: org_study_id

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