Retinal DiseaseRetine-FochNCT04956237
Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort
An observational study of Retinal Disease, run by Hopital Foch at 2 sites in France.
Trial summary
Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease
- Type of treatment
- Injection or infusion
- How many people
- 164 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Sep 2021to 29 Feb 2024
- 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: Any patient over 18 years of age undergoing retinal surgery including retinal detachment, epi-retinal membrane-internal limiting peel, macular hole, implant dislocation, vitrectomy, revision of capsular rupture
Who may be able to join
- Patients over 18 years old
- Patients with an indication for retinal surgery
- Not having opposed to participate in the study
Who cannot join
- Claustrophobia
- Unbalanced psychiatric pathology
- Inability to lie down
- Deprived of liberty or under guardianship.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique Pierre Cherest
Neuilly-sur-Seine, 92200
Foch Hospital
Suresnes, 92150
About this study
Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head.
Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist.
Read more
The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route.
To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia.
This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route.
For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.
- Conditions
- Retinal Disease
- Keywords
- Peribulbar surgery, Tenonian surgery, Retinal surgery, Surgeon comfort, Patient comfort
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tenonian surgery | Hospital recruitment with outpatient surgery without the presence of an anesthesiologist, without loco-regional anesthesia and without intravenous route | |
| Peribulbar surgery | Gold standard: City recruitment with outpatient surgery with the presence of an anesthesiologist and with loco-regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia
Number of eye or head movements of the patient during the operation
Measured: At the surgery
Secondary outcomes (4)
Comparison of the patient's comfort during the operation between the 2 groups
Postoperative Iowa Satisfaction with Anesthesia Scale (ISAS) Score rated from 11 (worse outcome) to 66 (better outcome)
Measured: 15 minutes after the end of the surgery
Comparison of the patient's comfort during the operation between the 2 groups regarding pain
Visual analogic scale (VAS) of pain during the surgery rated from 0 "No pain" to 10 "worst possible pain"
Measured: Preoperative, peroperative and 15 minutes post surgery
Comparison of operating time between the 2 groups
Operating time
Measured: At the end of the surgery
Assessement of the security between the 2 groups
Intraoperative complications and peroperative events
Measured: At the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start9 Sep 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956237
- Sponsor's protocol ID
- 2020_0138
- Acronym
- Retine-Foch
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Surgery With or Without Anesthesiologist, Comparison of Surgeon and Patient's Comfort
- ClinicalTrials.gov ID
- NCT04956237
- Acronym / sponsor ID
- Retine-Foch / 2020_0138
- Conditions
- Retinal Disease
- Keywords
- Peribulbar surgery, Tenonian surgery, Retinal surgery, Surgeon comfort, Patient comfort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 9 Jul 2021 (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.
Retinal surgeries are now performed in some hospitals with sub-Tenon anesthesia to replace conventional peribulbar anesthesia. The advantages of performing the surgery with Tenonian anesthesia can be: the cost reduced due to the non-intervention of an anesthesiologist, no pre-operative anesthetic consultation, no waiting period for the effectiveness of the peribulbar anesthesia (15-20min to have the effect of anesthesia of the eye). In addition, there are more numerous and dangerous complications of peribulbar anesthesia than sub-Tenonian anesthesia, however it allows the eye to remain stationary and to perform precise surgery safely, as long as the patient does not move his head.
Performing a sub-Tenonian anesthesia also makes it possible to carry out surgeries more quickly, this method having an immediate effect and being performed by the surgeon, without the intervention of an anesthesiologist.
The edema effect under the post / conjunctiva swells the area around the eye and allows partial oculomotor limitation. Finally, for the patient, recovery is faster: no sedation or venous route.
To date, however, no study has proven that the surgeon can safely operate on the patient without increased complications compared to peribulbar anesthesia.
This study aims to show that simple sub-Tenonian anesthesia in a short outpatient circuit does not induce more pain or discomfort for the patient than a longer outpatient circuit with bed and anesthesiologist. No studies have been performed on purely local anesthesia without a venous route.
For this, patients operated on at the Foch hospital without an anesthesiologist under subtenon's anesthesia will be compared to patients operated on under peribulbar anesthesia with an anesthesiologist at the Pierre Cherest clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenonian surgery | – | –Hospital recruitment with outpatient surgery without the presence of an anesthesiologist, without loco-regional anesthesia and without intravenous route |
| Peribulbar surgery | – | –Gold standard: City recruitment with outpatient surgery with the presence of an anesthesiologist and with loco-regional anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient over 18 years of age undergoing retinal surgery including retinal detachment, epi-retinal membrane-internal limiting peel, macular hole, implant dislocation, vitrectomy, revision of capsular rupture
Key inclusion criteria (3 listed)
- Patients over 18 years old
- Patients with an indication for retinal surgery
- Not having opposed to participate in the study
Key exclusion criteria (4 listed)
- Claustrophobia
- Unbalanced psychiatric pathology
- Inability to lie down
- Deprived of liberty or under guardianship.
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
Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia
Time frame: At the surgery
Number of eye or head movements of the patient during the operation
4 secondary outcomes
Comparison of the patient's comfort during the operation between the 2 groups
Time frame: 15 minutes after the end of the surgery
Comparison of the patient's comfort during the operation between the 2 groups regarding pain
Time frame: Preoperative, peroperative and 15 minutes post surgery
Comparison of operating time between the 2 groups
Time frame: At the end of the surgery
Assessement of the security between the 2 groups
Time frame: At the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease, run by Hopital Foch at 2 sites 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 4 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: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the comfort and safety of the surgeon between patients operated with peribulbar or tenonian anesthesia (time frame: At the surgery). 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 31 Jul 2024.