Evaluation of a Protocol of Pupil Dilation Before Laser-a... | NCT03375996

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

NCT03375996

Sponsor

CHU de Reims

Status

Completed

Last Update Posted

Aug 22, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Cataract Surgery

Interventions

cyclopentolate 0.5% eye drops

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Aug 21, 2024Actual

Completion Date

Aug 21, 2024Actual

First Submitted Date

Dec 7, 2017

First Submission Date that Met QC Criteria

Dec 15, 2017

First Posted Date

Dec 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2024

Last Update Posted Date

Aug 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FLACS group		Patient presenting cataract and scheduled for laser-assisted cataract surgery	Drug: cyclopentolate 0.5% eye drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cyclopentolate 0.5% eye drops	Drug	cyclopentolate 0.5% eye drops and measurement of the pupillary mydriasis (dilatation)	FLACS group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Pupil diameter variation at each time of the surgery		Day 0
Surgeon satisfaction	questionnaire	Day 0

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with cataract scheduled for laser-assisted cataract surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Reims		Reims		51092	France

Intervention Browse Module

MeSH Terms

ID	Term
D003519	Cyclopentolate
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

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Browse Branches

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