CataractCATARIDENCT02903485
Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study
A study testing nurses perform presurgical assessement and surveillance during surgery and the anesthetic team performs presurgical assessement and surveillance during surgery in people with Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- nurses perform presurgical assessement and surveillance during surgery and the anesthetic team performs presurgical assessement and surveillance during surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2015to Jan 2018
- Phase
- Interventional
- 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
Who may be able to join
- age > 18 years old
- cataract surgery scheduled with topical anesthetics
- outpatient surgery
Who cannot join
- presurgical nurse assessment leading to the need for the anesthetic staff presence during surgery
- general, peribulbar or other locoregional anesthesia required by patient's condition
- concomitant surgery planified (glaucoma, vitrectomy…)
- patient's refusal to participate in the study
- no health insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia.
The nurse performs the triage of patients based on a chart of risk factors assessment. The triage, according to the presence or not of risk factors, leads to patients' care by an anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for surveillance during surgery) or to patients' pre-surgical assessement and surveillance during surgery both performed only by nurses.
In the control group, all patients are taken care of by an aesthetic team, with medical pre surgical assessement and surveillance during surgery both performed by anesthetic nurses.
- Conditions
- Cataract
- Being tested
- nurses perform presurgical assessement and surveillance during surgery, the anesthetic team performs presurgical assessement and surveillance during surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurses perform presurgical assessement and surveillance during surgeryOther
the anesthetic team performs presurgical assessement and surveillance during surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| nurses (intervention arm) | Experimental | for patients without risk factors, the anesthetic team is not involved in patients' care Receives: Other: nurses perform presurgical assessement and surveillance during surgery |
| anesthetic team (control arm) | Active comparator | the anesthetic team is involved in every patient's care (with or without risk factors) Receives: Other: the anesthetic team performs presurgical assessement and surveillance during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
complications occuring in operating theatre include systolic blood pressure > 200 mmHg or < 80 mmHg, diastolic blood pressure > 110 mmHg, heart rate < 45/mn for at least 1 mn, oxygen saturation (SpO2) <90% for at least 1 mn, impossibility to start or to pursue surgery because of patient condition.
Measured: through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2018
- Study completionJan 2018
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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Devys, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903485
- Sponsor's protocol ID
- JMD_2014-31
- Acronym
- CATARIDE
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2016
- Last updated
- 7 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study
- ClinicalTrials.gov ID
- NCT02903485
- Acronym / sponsor ID
- CATARIDE / JMD_2014-31
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia.
The nurse performs the triage of patients based on a chart of risk factors assessment. The triage, according to the presence or not of risk factors, leads to patients' care by an anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for surveillance during surgery) or to patients' pre-surgical assessement and surveillance during surgery both performed only by nurses.
In the control group, all patients are taken care of by an aesthetic team, with medical pre surgical assessement and surveillance during surgery both performed by anesthetic nurses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurses (intervention arm) | Experimental | Other: nurses perform presurgical assessement and surveillance during surgeryfor patients without risk factors, the anesthetic team is not involved in patients' care |
| anesthetic team (control arm) | Active comparator | Other: the anesthetic team performs presurgical assessement and surveillance during surgerythe anesthetic team is involved in every patient's care (with or without risk factors) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 years old
- cataract surgery scheduled with topical anesthetics
- outpatient surgery
Key exclusion criteria (5 listed)
- presurgical nurse assessment leading to the need for the anesthetic staff presence during surgery
- general, peribulbar or other locoregional anesthesia required by patient's condition
- concomitant surgery planified (glaucoma, vitrectomy…)
- patient's refusal to participate in the study
- no health insurance coverage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurses perform presurgical assessement and surveillance during surgery | Other | nurses (intervention arm) |
| the anesthetic team performs presurgical assessement and surveillance during surgery | Other | anesthetic team (control arm) |
Primary outcome
Incidence of complications
Time frame: through study completion, up to 6 months
complications occuring in operating theatre include systolic blood pressure > 200 mmHg or < 80 mmHg, diastolic blood pressure > 110 mmHg, heart rate < 45/mn for at least 1 mn, oxygen saturation (SpO2) <90% for at least 1 mn, impossibility to start or to pursue surgery because of patient condition.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
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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.
Jean-Michel Devys, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurses perform presurgical assessement and surveillance during surgery and the anesthetic team performs presurgical assessement and surveillance during surgery in people with Cataract, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Dec 2018. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications (time frame: through study completion, up to 6 months). 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 7 Dec 2018.