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

ConditionsCataract and IOL SurgeryEpi-retinal Membrane
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDebbie Kuo, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • cataract surgery

    Device

    cataract surgery receiving Vivity IOL or standard mono focal controls

  • retinal surgery

    Procedure/Surgery

    Retinal surgery for visually significant epiretinal membrane

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Vivity Extended Depth of Focus IOLExperimental treatment 2 interventions
Group B: Standard monofocal IOLActive comparator 2 interventions

Trial outcomes

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

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Debbie Kuo, MD

Lead sponsor

Sutter Health

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: