Clinical Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens (NCT07473557) | Clinical Trial Compass
CompletedNot Applicable
Clinical Outcomes of the Use of a Femtosecond Laser on an Implanted Intraocular Lens
Panama12 participantsStarted 2019-01-18
Plain-language summary
This is a prospective non-randomized patient controlled single center study which is designed to evaluate the clinical outcomes of the treatment of an implanted intraocular lens using a low-energy femtosecond laser for refractive correction.
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.
. Subject has undergone cataract surgery and has had an AMO ZCB00/PCB00/AAB00 in at least one eye (only one eye will be treated).
. Subject has post-operative refractive error of one diopter or more of spherical, cylinder or sphero-cylinder difference from desired refraction.
. 20/40 or better BCDVA at 4m.
Exclusion criteria
. Subject not able to complete the informed consent form.
. Astigmatism greater than 3 diopter.
. Spherical diopter error of greater than 4 diopters.
. Combined spherical and cylinder diopter error of greater than 5 diopters.
. 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.
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 used a femtosecond laser directly on an already-implanted intraocular lens to correct refractive errors — how does that approach compare to simply replacing or adjusting my existing lens, and which option might be safer for my situation?
2Since this trial has already completed, has my doctor seen any of the results showing how much the spherical equivalent (the measure of overall refractive error) actually changed after the laser treatment, and were the improvements clinically meaningful?
3The trial tracked device-related adverse events as a primary safety endpoint — what kinds of complications were they specifically watching for when using a femtosecond laser on an implanted lens, and how common were they?
4Because this study is listed as Phase NA, meaning it's evaluating a device rather than following the usual drug trial phases, what does that mean for how confident we can be in the safety and effectiveness data it generated?
5If the results from this completed trial look promising, is this femtosecond laser approach something my doctor could offer me now, or is it still considered experimental and not yet available as a standard treatment option?
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
Primary Endpoint - Change in mean manifest refraction spherical equivalent ("MRSE") (post- versus pre-treatment)
Timeframe: Between pre-treatment and 1 week post-treatment.
2
Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-treatment)
Timeframe: Between pre-treatment and 1 week, 1 month and 3 months post-treatment.
3
Safety Endpoint - Primary Device Related Adverse Events (post- versus pre-treatment)
Timeframe: Between pre-treatment and 1 month and 3 months post-treatment.
. Previous refractive surgery or proposed refractive surgery procedures throughout the entire duration of the subject's 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, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes, including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration.