Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery (NCT02898909) | Clinical Trial Compass
TerminatedNot Applicable
Comparison of Two Fragmentation Modalities in Femtosecond Laser-assisted Cataract Surgery
Stopped: Major inclusion difficulties
France5 participantsStarted 2016-11-15
Plain-language summary
Femtosecond laser-assisted cataract surgery consists in nuclear lens fragmentation, followed by ultrasound phacoemulsification of nuclear lens, which is then removed.
It can be assumed that fragmenting the nuclear lens in more pieces could facilitate the post-laser ultrasound phacoemulsification to extract the lens, with a lesser amount of ultrasonic energy.
The decrease of ultrasonic energy delivered during cataract surgery is beneficial to the patient because it optimizes the vitality of corneal endothelial cells, which ensure corneal transparency.
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:
* patient aged ≥ 18 years old
* first Femtosecond Laser-assisted Cataract Surgery scheduled
* cataract density ≥ 3 according to the lens opacities classification system (LOCS)
Exclusion Criteria:
* corneal guttata, uncontrolled glaucoma
* shallow depth of anterior chamber
* patient's refusal to participate in the study
* pregnant or breast feeding patient
* patient under legal protection
* no health coverage
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
energy delivered for lens nucleus aspiration during phacoemulsification
Timeframe: approximatively 15 minutes
Trial details
NCT IDNCT02898909
SponsorFondation Ophtalmologique Adolphe de Rothschild