NCT04353843

Brief Summary

Adults who undergo cataract surgery will be questioned after surgery about the eventual pain they experienced, about their health history, personal treatment. If they accept to be included in the study we'll record different parameters related to the surgery: type of anesthesia, duration of surgery, machines used, unexpected events, particularities noticed by the surgeon, etc. There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

April 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

April 17, 2020

Last Update Submit

June 4, 2020

Conditions

Cataract

Keywords

Cataract surgeryPhakoemulsificationPainBiometryAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Pain during cataract surgery

    Visual Analog Scale of pain

    1 day

Secondary Outcomes (1)

  • assess the rate of intraoperative complications over the series

    1 day

Eligibility Criteria

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

Secondary care population from two clinics and two university hospitals from 3 cities in total, who undergo cataract surgery

You may qualify if:

  • Majority 18 years and more

You may not qualify if:

  • \- General anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

CataractPain

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vincent Daien, MD, PhD, HDR

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Daien, MD, PhD, HDR

CONTACT

67336966v-daien@chu-montpellier.fr

Francois Ortis, intern

CONTACT

638651575ortis@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 20, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 30, 2021

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

FR(1)