Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery

Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210

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.

Study Overview

• Status: Unknown
• Conditions: Cataract

Detailed Description

Adults who undergo cataract surgery, excepting under general anesthesia, will be asked to rate a Visual Analog Scale grading the 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: Visual analog scale of pain according to the surgeon (before recording the patient), type of anesthesia, duration of surgery, machines used, time of ultrasound used for phakoemulsification, preoperoative visual acuity and intraocular pressure, biometry, iris color, preoperative donesis, preoperative capsular pseudoexfolliation, unexpected events, particularities noticed by the surgeon as Floppy iris syndrome, Lens-iris diaphragm retropulsion syndrome There will be no unusual intervention, everything will be run exactly as if there was no study. No additional consultation needed.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UH Montpellier
    • Contact: Francois Ortis; Phone Number: 33 638651575; Email: francois.ortis@gmail.com
    • Principal Investigator: Didier Audemard
    • Sub-Investigator: Elodie Marck
    • Sub-Investigator: Arnaud Payerol
    • Principal Investigator: Christophe Chassain
    • Principal Investigator: Arnaud Payerols

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion criteria:

• Undergoing a cataract surgery during the period of inclusion, and by one of the surgeons of the study
• Majority 18 years and more

Exclusion criteria:

- General anesthesia

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain during cataract surgery	Visual Analog Scale of pain	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the rate of intraoperative complications over the series	assess the rate of intraoperative complications over the series	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Centre Hospitalier Universitaire de Nīmes; Beziers Champeau Clinic; Montpellier Beau Soleil Clinic; Montpellier Ophtalmology Center
• Investigators: Principal Investigator: Vincent DAIEN, MD, PhD, HDR, University Hospitals of Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Cataract surgery; Anesthesia; Biometry; Phakoemulsification
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: RECHMPL20_0210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No