Study of the Efficiency and Workflow of Femtosecond Laser Assisted Cataract Surgery in a Spanish … (NCT03931629) | Clinical Trial Compass
CompletedNot Applicable
Study of the Efficiency and Workflow of Femtosecond Laser Assisted Cataract Surgery in a Spanish Public Hospital
167 participantsStarted 2016-01-01
Plain-language summary
Purpose: To assess the time-efficiency of a designated operation room (OR) workflow in the introduction of Femtosecond laser-assisted cataract surgery (FLACS, LenSx, Alcon®). The study was carried out in a public hospital with high volume of procedures.
Setting: Ophthalmology department of a tertiary referral Spanish public hospital.
Design: Prospective, controlled, surgical intervention study. Methods: A total of 167 eyes were enrolled, including 62 eyes undergoing conventional phacoemulsification surgery. In phase I, patients were assigned either to FLACS-I (n=63) or conventional phacoemulsification surgery (n=62). One surgeon operated the Femto-second laser, another finished the procedure, whereas another performed a conventional phacoemulsification. In the second phase (FLACS-II), all the surgeries were FLACS (n=42). A surgeon performed the FLACS procedure and two different surgeons completed the surgeries in separated ORs. Surgical and roll-over times of all the patients were recorded.
Who can participate
Age range
18 Years – 100 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:
* Informed consent signing.
* Over 18 years old.
* No medical contraindication for cataract surgery.
* Maximum best-corrected visual acuity \[BCVA\] 0.4 logMAR.
* Patients with easily accessible sockets.
* Minimal pupil mydriasis of 6 mm.
* Anticipated good patient collaboration.
Exclusion Criteria:
* No informed consent signing.
* Patients under 18 years old.
* Medical contraindication for cataract surgery.
* Maximum best-corrected visual acuity \[BCVA\] over 0.4 logMAR.
* Patients with badly accessible sockets.
* Maximal mydriasis inferior to 6 mm.
* Poor patient collaboration were included.
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
WORKFLOW IN THE OPERATION ROOM (minutes)
Timeframe: Operation day
Trial details
NCT IDNCT03931629
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud