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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03375996
Recruitment Status : Unknown
Verified December 2019 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : December 18, 2017
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Cataract Surgery Drug: cyclopentolate 0.5% eye drops

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of a Preoperative Pharmacological Protocol for Mydriasis in Femtosecond Laser-assisted Cataract Surgery
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort Intervention/treatment
FLACS group
Patient presenting cataract and scheduled for laser-assisted cataract surgery
 Drug: cyclopentolate 0.5% eye drops
cyclopentolate 0.5% eye drops and measurement of the pupillary mydriasis (dilatation)


Outcome Measures
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Primary Outcome Measures :
  1. Pupil diameter > 6 mm all along the surgical procedure [ Time Frame: Day 0 ]
    a posteriori pupil measurement using the peroperative movie recorded via the operative microscope during each surgery.


Secondary Outcome Measures :
  1. Pupil diameter variation at each time of the surgery [ Time Frame: Day 0 ]
  2. Surgeon satisfaction [ Time Frame: Day 0 ]
    questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cataract scheduled for laser-assisted cataract surgery
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375996


Contacts
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Contact: Alexandre DENOYER 3 10 73 66 78 ext 0033 adenoyer@chu-reims.fr

Locations
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France
Chu Reims Recruiting
Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03375996    
Other Study ID Numbers: PO17111
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Ophthalmic Solutions
Cyclopentolate
Pharmaceutical Solutions
Mydriatics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action