Skip to content

Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02903485
Acronym
CATARIDE
Enrollment
578
Registered
2016-09-16
Start date
2015-12-31
Completion date
2018-01-31
Last updated
2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief 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. 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.

Interventions

OTHERnurses perform presurgical assessement and surveillance during surgery
OTHERthe anesthetic team performs presurgical assessement and surveillance during surgery

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age \> 18 years old * cataract surgery scheduled with topical anesthetics * outpatient surgery

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of complicationsthrough study completion, up to 6 monthscomplications 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026