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

D

Debbie Kuo, MD

Status

Not yet enrolling

Conditions

Epi-retinal Membrane
Cataract and IOL Surgery

Treatments

Procedure: retinal surgery
Device: cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07070492
2025.067-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Vivity Extended Depth of Focus IOL
Experimental group
Treatment:
Device: cataract surgery
Procedure: retinal surgery
Standard monofocal IOL
Active Comparator group
Treatment:
Device: cataract surgery
Procedure: retinal surgery

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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