Cataract and IOL Surgery, Epi-retinal Membrane
Conditions
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.
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
DEVICEcataract surgery
cataract surgery receiving Vivity IOL or standard mono focal controls
PROCEDUREretinal surgery
Retinal surgery for visually significant epiretinal membrane
Sponsors
Debbie Kuo, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vision Acuity | At the study visit at least 3 months after the combined cataract and retinal surgeries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Outcome results
None listed