NCT03375996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

6.2 years

First QC Date

December 7, 2017

Last Update Submit

August 21, 2024

Conditions

Cataract Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Pupil diameter variation at each time of the surgery

    Day 0

  • Surgeon satisfaction

    Day 0

Study Arms (1)

FLACS group

Patient presenting cataract and scheduled for laser-assisted cataract surgery

Drug: cyclopentolate 0.5% eye drops

Interventions

cyclopentolate 0.5% eye dropsDRUG

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

FLACS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cataract scheduled for laser-assisted cataract surgery

You may qualify if:

  • Patient with unilateral or bilateral cataract requiring a cataract surgery
  • Patient scheduled for laser-assisted cataract surgery

You may not qualify if:

  • Subject with general medication influencing iris state and/or pupil dilation (alpha-agonist, psychotropic drugs)
  • Subject unable to give informed consent
  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Interventions

CyclopentolateOphthalmic Solutions

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

December 18, 2017

Study Start

June 1, 2018

Primary Completion

August 21, 2024

Study Completion

August 21, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations

FR(1)