Visual Outcomes and Quality of Life After Vivity EDOF IOL Implantation in Early-Stage Keratoconus (NCT07338708) | Clinical Trial Compass
CompletedNot Applicable
Visual Outcomes and Quality of Life After Vivity EDOF IOL Implantation in Early-Stage Keratoconus
Italy10 participantsStarted 2024-09-17
Plain-language summary
The goal of this clinical trial is to learn if the Vivity Extended Depth of Focus intraocular lens works to improve vision in adults with cataracts and early-stage keratoconus. It will also learn about the safety and tolerance of this premium lens in patients with mild corneal irregularities. The main questions it aims to answer are:
* Does the Vivity EDOF lens provide good distance vision (20/25 or better) in the dominant eye at 3 months after surgery?
* Does it improve vision at intermediate and near distances compared to before surgery?
* Does it preserve contrast sensitivity and optical quality despite mild corneal irregularities?
* What is the patient-reported quality of life and satisfaction after implantation?
* What visual disturbances (such as halos) do participants experience?
All participants will:
* Receive the Vivity EDOF intraocular lens (or its toric version if astigmatism is present) in both eyes during standard cataract surgery, with the second eye operated within 7 days;
* Undergo comprehensive eye examinations before surgery including vision testing, corneal imaging, and optical quality measurements;
* Attend a follow-up visit at 3 months after surgery for detailed vision testing at multiple distances, contrast sensitivity testing under different lighting conditions, halo assessment, and quality-of-life questionnaires.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults requiring bilateral cataract surgery
* Mild bilateral keratoconus defined as stage 0-1 according to the ABCD classification system
* Keratoconus stability defined as maximum keratometry (K) changes less than 1 diopter and maximum pachymetry reduction less than 2% within the previous 5 years
* Pre-cataract spectacle distance-corrected visual acuity of 0.1 to 0.0 LogMAR (Snellen 20/25 to 20/20)
* Agreement to bilateral implantation of AcrySof IQ Vivity Extended Depth of Focus intraocular lens
* Willingness to undergo second-eye surgery within 7 days after first-eye procedure
* Ability and willingness to attend all scheduled follow-up visits as per study protocol
* Provision of written informed consent to participate in the study
Exclusion Criteria:
* Any ocular comorbidities other than cataract and keratoconus, or history of any disease that could affect visual results (e.g., glaucoma, retinal disorders)
* Corneal opacity including any corneal scarring
* Advanced or progressive keratoconus
* Any previous ocular surgery other than corneal cross-linking performed at least 5 years prior to enrollment
* Corneal cross-linking performed within 5 years prior to enrollment
* Amblyopia
* Pseudoexfoliation syndrome or zonular laxity
* History of uveitis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distance-Corrected Visual Acuity in the Dominant Eye