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Not yet recruiting NCT07070492

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

No phase Interventional Cataract and IOL Surgery Epi-retinal Membrane

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cataract surgery, retinal surgery.
Who it may be relevant to
Registry conditions: Cataract and IOL Surgery, Epi-retinal Membrane. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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.

Interventions

  • Device cataract surgery
    cataract surgery receiving Vivity IOL or standard mono focal controls
  • Procedure retinal surgery
    Retinal surgery for visually significant epiretinal membrane

Primary outcome measures

  • Vision Acuity [Time frame: At the study visit at least 3 months after the combined cataract and retinal surgeries]
Secondary outcome measures (2)
  • Contrast Sensitivity [Time frame: 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 [Time frame: At the study visit at least 3 months after the combined cataract and retinal surgeries]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07070492 · 2025.067-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗