StrabismusSTRABONCT02360969
Effect of Neuromuscular Blockade on the Oculomotor by Not Squinting Child
An observational study of Strabismus, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Strabismus is a common condition (4-6% of the population) . The screening and treatment is a public health issue. Indeed, beyond the disfigurement, this disease is very supplier of amblyopia which is definitive if it is not detected and treated early (before 6 years old). Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Strabismus
- What is being tested?
- Examination of the eye
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2010to Dec 2016
- 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients for whom surgery under general anesthesia with administration of curare is planned
Who may be able to join
- normal visual acuity for age: 10/10 (Test of Cadet) Rossano 2 for 4-6 years old. 10/10 (scale Monoyer) Parnaud 1.5 for 7-15 years old.
- normal oculomotor examination: Examination under normal alternating display eliminating strabismus
- Binocular vision less than or equal to 60 sec/arc for the stereoscopic vision test
- Refraction WITHOUT cycloplegia within normal limits: below 2 dioptries myopia, hyperopia less than 1.5d, below 1 dioptry astigmatism, anisometropia less than 1 dioptry.
- Examination of the fundus without normal pupillary dilation
- Axial length 6 normal for age as measured by noncontact biometer to eliminate refractive offset anomaly axial length by abnormal
Who cannot join
- presence of anterior eye history
- children whose behavior suggests a poor cooperation when taking photo awakeness
- children with abnormal limb
- scheduled surgery without the use of curare
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Nantes
Nantes, 44000
Centre Hospitalier Universitaire de Saint Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 69003
About this study
Strabismus is a common condition (4-6% of the population) . The screening and treatment is a public health issue. Indeed, beyond the disfigurement, this disease is very supplier of amblyopia which is definitive if it is not detected and treated early (before 6 years old).
Initial treatment of strabismus is medical with orthoptic reeducation through penalization of the better eye in case of amblyopia or wearing optical correction in case of associated refractive disorder.
Read more
The second step is the treatment of strabismus is the surgery, when medical treatment has not resulted in a recovery of the visual axes. The principle of surgery is to weaken or strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint deviation. The main difficulty of surgical treatment is to assess the amount of strengthening or weakening muscles to do in order to obtain the best result and for a long time.
The investigators know that the postmortem anatomical position of the eyes is generally a slight elevation and divergence, but is inferior to the angle of divergence of the orbital axes. Curare and similar products which inhibit the nervous transmission at the neuromuscular junction, can be used to reproduce this situation in normal subjects.
The sign of general anesthesia is then to evaluate the angle of strabismus when the patient is under deep general anesthesia and with a complete muscle relaxation, obtained only when curarised it. If one or both eyes are recovering under general anesthesia, strabismus is mainly due to dynamic changes and surgery limiting muscle play (wire operation) and sometimes one eye is justified. A combination of both is possible (down + wireless), guided by the importance of the sign of general anesthesia on two prominent eyes or one eye. This sign of general anesthesia is however less known and most poorly quantified in healthy subjects. Yet it seems very important to determine what is deviation in normal subjects after neuromuscular blockade, as his eye movement is also subject to mechanical factors and spastic. This would indicate whether the state of rectitude (no strabismus) is the result of a deviation at complete rest (appearing under general anesthesia) and corrected by spastic elements wakefulness or, in another case this righteousness is already present in the state of general anesthesia (due to static factors) and slightly modified by enlightenment.
- Conditions
- Strabismus
- Being tested
- Examination of the eye
- Keywords
- strabismus, surgical procedure, anesthesia, squint, child
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of the eyeOther
Before planed surgery, an ophthalmologist measures the patient's visual acuity and realise an oculomotor examination. Measurement the refraction and the axial length of the eye is performed. Photographs wakefulness are performed.
During surgery, participation in this study does not involve any change in the course of anesthesia and surgery.
Pictures of the eye will be performed under general anesthesia.
Timing photos will be dictated by the values of BIS and train-of-four (TOF). Photos will be conducted at different times, with the "top" given by the anesthetist under the following conditions:
Deep anesthesia: BIS <50 Deep anesthesia and muscle relaxation: BIS <50 and TOF 0/4
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects waiting for surgery | patients for whom surgery under general anesthesia with administration of curare is planned will be offered an examination of the eyes before and during surgery Receives: Other: Examination of the eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal deflection of the two eyes under deep general anesthesia and under curare
When the patient is under deep general anesthesia (Bispectral Index (BIS) < 50) ,one photo is taken. A seconde one is taken after curare induction.
Measured: From the anesthesia to the end of the surgery
Secondary outcomes (1)
Horizontal deflection of the two eyes under deep general anesthesia
Before the anesthesic induction, one photo is taken. A seconde one is taken when the patient is under deep general anesthesia (Bispectral Index (BIS) < 50)
Measured: From the anesthesia to 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 posted11 Feb 2015 (estimated)
- Study startNov 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre PM MANOLI, M.D, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360969
- Sponsor's protocol ID
- 0908125
- Other IDs
- 2010-021022-35
- Acronym
- STRABO
- Status last verified
- Jan 2017
- First submitted
- 3 Feb 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Blockade on the Oculomotor by Not Squinting Child
- ClinicalTrials.gov ID
- NCT02360969
- Acronym / sponsor ID
- STRABO / 0908125
- Conditions
- Strabismus
- Keywords
- strabismus, surgical procedure, anesthesia, squint, child
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Feb 2015 (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.
Strabismus is a common condition (4-6% of the population) . The screening and treatment is a public health issue. Indeed, beyond the disfigurement, this disease is very supplier of amblyopia which is definitive if it is not detected and treated early (before 6 years old).
Initial treatment of strabismus is medical with orthoptic reeducation through penalization of the better eye in case of amblyopia or wearing optical correction in case of associated refractive disorder.
The second step is the treatment of strabismus is the surgery, when medical treatment has not resulted in a recovery of the visual axes. The principle of surgery is to weaken or strengthen one or more extraocular muscles of one (or two) eye to correct the eyes squint deviation. The main difficulty of surgical treatment is to assess the amount of strengthening or weakening muscles to do in order to obtain the best result and for a long time.
The investigators know that the postmortem anatomical position of the eyes is generally a slight elevation and divergence, but is inferior to the angle of divergence of the orbital axes. Curare and similar products which inhibit the nervous transmission at the neuromuscular junction, can be used to reproduce this situation in normal subjects.
The sign of general anesthesia is then to evaluate the angle of strabismus when the patient is under deep general anesthesia and with a complete muscle relaxation, obtained only when curarised it. If one or both eyes are recovering under general anesthesia, strabismus is mainly due to dynamic changes and surgery limiting muscle play (wire operation) and sometimes one eye is justified. A combination of both is possible (down + wireless), guided by the importance of the sign of general anesthesia on two prominent eyes or one eye. This sign of general anesthesia is however less known and most poorly quantified in healthy subjects. Yet it seems very important to determine what is deviation in normal subjects after neuromuscular blockade, as his eye movement is also subject to mechanical factors and spastic. This would indicate whether the state of rectitude (no strabismus) is the result of a deviation at complete rest (appearing under general anesthesia) and corrected by spastic elements wakefulness or, in another case this righteousness is already present in the state of general anesthesia (due to static factors) and slightly modified by enlightenment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects waiting for surgery | – | Other: Examination of the eyepatients for whom surgery under general anesthesia with administration of curare is planned will be offered an examination of the eyes before and during surgery |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients for whom surgery under general anesthesia with administration of curare is planned
Key inclusion criteria (6 listed)
- normal visual acuity for age: 10/10 (Test of Cadet) Rossano 2 for 4-6 years old. 10/10 (scale Monoyer) Parnaud 1.5 for 7-15 years old.
- normal oculomotor examination: Examination under normal alternating display eliminating strabismus
- Binocular vision less than or equal to 60 sec/arc for the stereoscopic vision test
- Refraction WITHOUT cycloplegia within normal limits: below 2 dioptries myopia, hyperopia less than 1.5d, below 1 dioptry astigmatism, anisometropia less than 1 dioptry.
- Examination of the fundus without normal pupillary dilation
Key exclusion criteria (4 listed)
- presence of anterior eye history
- children whose behavior suggests a poor cooperation when taking photo awakeness
- children with abnormal limb
- scheduled surgery without the use of curare
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 |
|---|---|---|
| Examination of the eyeBefore planed surgery, an ophthalmologist measures the patient's visual acuity and realise an oculomotor examination. Measurement the refraction and the axial length of the eye is performed. Photographs wakefulness are performed. During surgery, participation in this study does not involve any change in the course of anesthesia and surgery. Pictures of the eye will be performed under general anesthesia. Timing photos will be dictated by the values of BIS and train-of-four (TOF). Photos will be conducted at different times, with the "top" given by the anesthetist under the following conditions: Deep anesthesia: BIS <50 Deep anesthesia and muscle relaxation: BIS <50 and TOF 0/4 | Other | healthy subjects waiting for surgery |
Primary outcome
Horizontal deflection of the two eyes under deep general anesthesia and under curare
Time frame: From the anesthesia to the end of the surgery
When the patient is under deep general anesthesia (Bispectral Index (BIS) < 50) ,one photo is taken. A seconde one is taken after curare induction.
1 secondary outcome
Horizontal deflection of the two eyes under deep general anesthesia
Time frame: From the anesthesia to 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 25 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Pierre PM MANOLI, M.D principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Strabismus, run by Centre Hospitalier Universitaire de Saint Etienne 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 6 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 25 Jan 2017. 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?
Horizontal deflection of the two eyes under deep general anesthesia and under curare (time frame: From the anesthesia to the end of 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 25 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.