Cataract and IOL SurgeryNCT07070492
Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens
A study testing cataract surgery and retinal surgery in people with Cataract and IOL Surgery and Epi-retinal Membrane, run by Debbie Kuo, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract and IOL Surgery, Epi-retinal Membrane
- What is being tested?
- cataract surgery and retinal surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Cataract and IOL Surgery, Epi-retinal Membrane
- Being tested
- cataract surgery, retinal surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryDevice
cataract surgery receiving Vivity IOL or standard mono focal controls
retinal surgeryProcedure or surgery
Retinal surgery for visually significant epiretinal membrane
| Study group | Role | What they receive |
|---|---|---|
| Vivity Extended Depth of Focus IOL | Experimental | Not described Receives: Device: cataract surgery; Procedure: retinal surgery |
| Standard monofocal IOL | Active comparator | Not described Receives: Device: cataract surgery; Procedure: retinal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision Acuity
Measured: At the study visit at least 3 months after the combined cataract and retinal surgeries
Secondary outcomes (2)
Contrast Sensitivity
Measured: 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
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.
Measured: At the study visit at least 3 months after the combined cataract and retinal surgeries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract and IOL SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debbie Kuo, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Debbie Kuo, MD, Sutter Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070492
- Sponsor's protocol ID
- 2025.067-1
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Patient Report Outcomes on Quality of Life and satisfaction
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Combined Cataract Surgery With Retinal Surgery for Visually Significant Epiretinal Membrane With Vivity Versus Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT07070492
- Acronym / sponsor ID
- 2025.067-1
- Conditions
- Cataract and IOL Surgery, Epi-retinal Membrane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Debbie Kuo, MDUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivity Extended Depth of Focus IOL | Experimental | Device: cataract surgery, Procedure: retinal surgery |
| Standard monofocal IOL | Active comparator | Device: cataract surgery, Procedure: retinal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgerycataract surgery receiving Vivity IOL or standard mono focal controls | Device | Standard monofocal IOL, Vivity Extended Depth of Focus IOL |
| retinal surgeryRetinal surgery for visually significant epiretinal membrane | Procedure or surgery | Standard monofocal IOL, Vivity Extended Depth of Focus IOL |
Primary outcome
Vision Acuity
Time frame: At the study visit at least 3 months after the combined cataract and retinal surgeries
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Yes. Patient Report Outcomes on Quality of Life and satisfaction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery and retinal surgery in people with Cataract and IOL Surgery and Epi-retinal Membrane, run by Debbie Kuo, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision Acuity (time frame: At the study visit at least 3 months after the combined cataract and retinal surgeries). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.