Evaluation of a Protocol of Pupil Dilation Before Laser-assisted Cataract Surgery (NCT03375996) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Protocol of Pupil Dilation Before Laser-assisted Cataract Surgery
France60 participantsStarted 2018-06-01
Plain-language summary
Laser-assisted cataract surgery is an innovative and growing procedure to improve the safety and results of modern cataract surgery. However, this technique faces to some obstacles: economics in the one hand due to the cost and time spent for the laser procedure before the conventional surgery, and technical in the other hand, especially due to some loss of pupil dilation during the surgery, which is highly important to ensure a perfect procedure. The present study aims at assessing a pharmacological protocol to maintain an accurate pupil dilation all along the surgery in order to improve the whole procedure.
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 with unilateral or bilateral cataract requiring a cataract surgery
* Patient scheduled for laser-assisted cataract surgery
exclusion criteria :
* Limitation due to laser procedure (little orbits, corneal scares, lack of pharmacological mydriasis at the inclusion visit)
* Subject with general medication influencing iris state and/or pupil dilation (alpha-agonist, psychotropic drugs)
* Subject unable to give informed consent
* minors
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
Pupil diameter > 6 mm all along the surgical procedure