CataractNCT04353843
Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery
An observational study of Cataract, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2020to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Secondary care population from two clinics and two university hospitals from 3 cities in total, who undergo cataract surgery
Who may be able to join
- Undergoing a cataract surgery during the period of inclusion, and by one of the surgeons of the study
- Majority 18 years and more
Who cannot join
- General anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UH Montpellier
Montpellier, 34295
Vincent Daien, MD, PhD, HDR, 67336966 ext. 33, v-daien@chu-montpellier.fr
Francois Ortis, 638651575 ext. 33, francois.ortis@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract
- Keywords
- Cataract surgery, Phakoemulsification, Pain, Biometry, Anesthesia
- Medical subject headings
- Cataract, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during cataract surgery
Visual Analog Scale of pain
Measured: 1 day
Secondary outcomes (1)
assess the rate of intraoperative complications over the series
assess the rate of intraoperative complications over the series
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 May 2020
- Primary completion1 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Beziers Champeau Clinic, Montpellier Beau Soleil Clinic, Montpellier Ophtalmology Center
- Responsible party
- Sponsor
- Investigators
- Vincent Daien, MD, PhD, HDR, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353843
- Sponsor's protocol ID
- RECHMPL20_0210
- Status last verified
- Jun 2020
- First submitted
- 17 Apr 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Clinical, Biometrical and Operatory Factors Related to Pain During Cataract Surgery / RECHMPL20_0210
- ClinicalTrials.gov ID
- NCT04353843
- Acronym / sponsor ID
- RECHMPL20_0210
- Conditions
- Cataract
- Keywords
- Cataract surgery, Phakoemulsification, Pain, Biometry, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Beziers Champeau Clinic, Montpellier Beau Soleil Clinic, Montpellier Ophtalmology Center
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care population from two clinics and two university hospitals from 3 cities in total, who undergo cataract surgery
Key inclusion criteria (2 listed)
- Undergoing a cataract surgery during the period of inclusion, and by one of the surgeons of the study
- Majority 18 years and more
Key exclusion criteria (1 listed)
- General anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain during cataract surgery
Time frame: 1 day
Visual Analog Scale of pain
1 secondary outcome
assess the rate of intraoperative complications over the series
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Daien, MD, PhD, HDR principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Daien, MD, PhD, HDR (67336966 ext. 33, v-daien@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during cataract surgery (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.