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OpenTrials
Completed

NCT Number: NCT03375996

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Reims

Reims, 51092, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclopentolate 0.5% eye drops

Drug

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

Primary outcomes

  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 outcomes

  1. Pupil diameter variation at each time of the surgery

    Time frame: Day 0

  2. Surgeon satisfaction

    Time frame: Day 0

    questionnaire

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: MYFLACS

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2017
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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