Evaluation of a Protocol of Pupil Dilation Before Laser-assisted Cataract Surgery

Cataract Surgery Clinical Trial

— MYFLACS  

Official title:

Evaluation of a Preoperative Pharmacological Protocol for Mydriasis in Femtosecond Laser-assisted Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03375996
• Other study ID #: PO17111
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: May 2020

Study information

• Verified date: December 2019
• Source: CHU de Reims
• Contact: Alexandre DENOYER
• Phone: 3 10 73 66 78
• Email: adenoyer[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Femtosecond laser-assisted cataract surgery (FLACS) is a major surgical development that would allow systematization of surgery and even improved safety of the procedure. The development of this new surgical technique must now face certain obstacles, in particular (i) financial considering the extra cost generated by the use of the laser and (ii) technique due to the need to re-learn certain gestures and certain variations related to the laser procedure and more specifically the instability of the pupillary mydriasis (dilatation) during the actual surgery. The use of a systematic preoperative pharmacological mydriasis protocol should allow maximum intraoperative mydriasis to be maintained, allowing satisfactory surgery throughout the procedure. Several drugs or medical devices are now indicated in cataract surgery, but their effectiveness has not been specifically evaluated for the laser technique. This study could thus make it possible to validate or not a protocol of mydriasis that could make consensus in the future for the practice of FLACS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery

Intervention

Drug:
• cyclopentolate 0.5% eye drops
cyclopentolate 0.5% eye drops and measurement of the pupillary mydriasis (dilatation)

Locations

Country	Name	City	State
France	Chu Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil diameter > 6 mm all along the surgical procedure	a posteriori pupil measurement using the peroperative movie recorded via the operative microscope during each surgery.	Day 0
Secondary	Pupil diameter variation at each time of the surgery		Day 0
Secondary	Surgeon satisfaction	questionnaire	Day 0