Clinical Outcomes of the Use of a Femtosecond Laser Treatment in a Patient With Implanted Monofoc… (NCT07447622) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Outcomes of the Use of a Femtosecond Laser Treatment in a Patient With Implanted Monofocal IOLs
Czechia12 participantsStarted 2026-03
Plain-language summary
This study aims to assess the safety and efficacy of evaluating near vision or refractive error in eyes implanted with a mono focal intraocular lens (IOL) using a low-energy femtosecond laser.
Who can participate
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
. Ability to understand study requirements, follow study instructions and to return for required study follow-up visits as confirmed by provision of written informed consent.
. Participant has undergone cataract surgery with an implantation of mono focal IOL.
. Participant has no significant residual visual issues which the Investigator believes would make the patient ill-suited for the treatment.
. Vision must be clinically stable in the Investigator's judgment.
. Each eye has Corrected Distance Visual Acuity (CDVA) of at least 0.2 logMAR (20/32).
. Participant has a mono focal intraocular lens implanted in both eyes.
. Both eyes have uncorrected distance visual acuity (UDVA) of 20/40 (0.3 logMAR) or better at 4 meters.
. Each eye has near vision assessed as Distance Corrected Near Visual Acuity (DCNVA) worse than Jeager 8 and/or ETDRS 0.5 logMAR.
Exclusion criteria
. Participants not able to complete the informed consent form.
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.
1This trial uses a femtosecond laser on eyes that already have monofocal IOLs implanted — can you explain what the laser is actually doing to the existing lens, and what risks that might carry given that my IOL is already in place?
2The trial isn't recruiting yet, so if I'm interested, how long might I realistically have to wait before I could even be considered, and what should I be doing in the meantime to manage my near vision or refractive error?
3The study is split into two cohorts — one focused on adding near vision and one on correcting refractive error — which of those would apply to my specific situation, and is my current prescription or vision problem the right fit for either?
4Since this is listed as Phase NA, meaning it may be more of an observational or device study rather than a traditional drug trial, can you help me understand how much is already known about the safety of using femtosecond lasers on eyes with implanted IOLs, and whether the risks are well-characterized?
5Are there already established options — like lens exchange, LASIK, or glasses — that could address my near vision or refractive error right now, and how would the potential benefits of waiting for this trial compare to starting one of those standard treatments today?
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
Safety (common for both cohorts)
Timeframe: 1 month post-treatment to the baseline visit.
2
Efficacy for Cohort 1 - Addition of Near Vision
Timeframe: Between pre-treatment and 1 month post-treatment.
3
Efficacy for Cohort 2 - Correction of Refractive Error
Timeframe: Between pre-treatment and 1 month post-treatment.
. Clinically significant corneal abnormalities including corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy), inflammation, keratitis, keratoconjunctivitis, keratouveitis, keratopathy, keratectasia or edema per the Investigator's expert medical opinion.
. Previous corneal surgery.
. Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the participants' participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions).
. History of or current retinal conditions or predisposition to retinal conditions including retinal detachment, diabetic retinopathy, age related macular degeneration which are assessed to by Investigator to confound outcomes.
. Amblyopia.
. History of or current anterior or posterior segment inflammation of any etiology, or any disease producing an inflammatory reaction in the eye (e.g., iritis or uveitis).