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NCT Number: NCT07070492

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

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.

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Key information

Conditions

Cataract and IOL Surgery Cataract Epi-retinal Membrane Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cataract surgery

Device

cataract surgery receiving Vivity IOL or standard mono focal controls

retinal surgery

Procedure

Retinal surgery for visually significant epiretinal membrane

Primary outcomes

  1. Vision Acuity

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

Secondary outcomes

  1. Contrast Sensitivity

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

  2. 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

    Using 5-point Likert scale, Research Insight's Validated PRO Questionnaire to assess patient overall satisfaction post-surgery, QOL on driving, reading, computer use, watching TV, sports, and Glare/Haloes.

Sponsors and collaborators

Lead sponsor

Debbie Kuo, MD

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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