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

NCT07070492 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025.067-1
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cataract and IOL Surgery; Epi-retinal Membrane

Outcome Measures

Primary Outcomes (1)

• Vision Acuity

  At the study visit at least 3 months after the combined cataract and retinal surgeries

Secondary Outcomes (2)

• Contrast Sensitivity

  At the study visit at least 3 months after the combined cataract and retinal surgeries

• Patient Reported Outcomes (PRO) on vision-related Quality of Life (QOL) and satisfaction

  At the study visit at least 3 months after the combined cataract and retinal surgeries

Study Arms (2)

Vivity Extended Depth of Focus IOL

EXPERIMENTAL

Device: cataract surgery; Procedure: retinal surgery

Standard monofocal IOL

ACTIVE COMPARATOR

Device: cataract surgery; Procedure: retinal surgery

Interventions

cataract surgery DEVICE

cataract surgery receiving Vivity IOL or standard mono focal controls

Standard monofocal IOL; Vivity Extended Depth of Focus IOL

retinal surgery PROCEDURE

Retinal surgery for visually significant epiretinal membrane

Standard monofocal IOL; Vivity Extended Depth of Focus IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Debbie Kuo, MD: lead

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Palo Alto Foundation Medical Group affiliated Ophthalmologist

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: After the final results were published and released to the public.
• Access Criteria: Researchers will have to make explicit request to the corresponding author to determine if any individual participant data can be released. No Personal Health Information and personal identifiers will be shared.