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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04353843
• Other study ID #: RECHMPL20_0210
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: Vincent Daien, MD, PhD, HDR
• Phone: 67336966
• Email: v-daien[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 30, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Locations

Country	Name	City	State
France	UH Montpellier	Montpellier

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Beziers Champeau Clinic, Montpellier Beau Soleil Clinic, Montpellier Ophtalmology Center, Nimes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain during cataract surgery	Visual Analog Scale of pain	1 day
Secondary	assess the rate of intraoperative complications over the series	assess the rate of intraoperative complications over the series	1 day