Strabismus, ComitantEOMSNCT05778565
Extraocular Muscle Stretching as a Weakening Procedure
A study testing Extraocular muscle stretching in people with Strabismus, Comitant, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Strabismus, Comitant
- What is being tested?
- Extraocular muscle stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2021to 23 Jun 2023
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery
Who cannot join
- Patients with previous strabismus surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stretching of an Extraocular Rectus Muscle as a Weakening Procedure
Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes.
Seven patients with esotropia of 12-20 PD were included.
- Conditions
- Strabismus, Comitant
- Being tested
- Extraocular muscle stretching
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraocular muscle stretchingProcedure or surgery
Extraocular muscle stretching to test its efficacy as a weakening procedure
| Study group | Role | What they receive |
|---|---|---|
| Extraocular muscle stretching arm | Experimental | Not described Receives: Procedure: Extraocular muscle stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance deviation at 2 months after surgery
Distance deviation at 2 months after surgery (alternate prim and cover)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start13 Jan 2021
- Primary completion23 Jun 2023 (estimated)
- Study completion23 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Strabismus, ComitantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Extraocular muscle procedure
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Tejedor, Universidad Autonoma de Madrid
- Investigators
- Jaime Tejedor, MD, PhD, Principal investigator, Universite Abdou Moumouni de Niamey, Niger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778565
- Sponsor's protocol ID
- OFTEOM-0322
- Acronym
- EOMS
- Status last verified
- May 2023
- First submitted
- 20 Feb 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When published
Publications
Tejedor J, Gutierrez-Carmona FJ. Extraocular Rectus Muscle Stretching as a Weakening Procedure. Ophthalmol Ther. 2023 Oct;12(5):2793-2800. doi: 10.1007/s40123-023-00756-3. Epub 2023 Jul 1.
PubMed 37392274
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stretching of an Extraocular Rectus Muscle as a Weakening Procedure
- ClinicalTrials.gov ID
- NCT05778565
- Acronym / sponsor ID
- EOMS / OFTEOM-0322
- Conditions
- Strabismus, Comitant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 23 Jun 2023 (estimated)
- Study completion
- 23 Jun 2023 (estimated)
- First posted
- 21 Mar 2023 (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.
Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes.
Seven patients with esotropia of 12-20 PD were included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Extraocular muscle procedure
| Arm | Type | Receives |
|---|---|---|
| Extraocular muscle stretching arm | Experimental | Procedure: Extraocular muscle stretching |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery
Key exclusion criteria (1 listed)
- Patients with previous strabismus surgery
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 |
|---|---|---|
| Extraocular muscle stretchingExtraocular muscle stretching to test its efficacy as a weakening procedure | Procedure or surgery | Extraocular muscle stretching arm |
Primary outcome
Distance deviation at 2 months after surgery
Time frame: 2 months
Distance deviation at 2 months after surgery (alternate prim and cover)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 37392274Tejedor J, Gutierrez-Carmona FJ. Extraocular Rectus Muscle Stretching as a Weakening Procedure. Ophthalmol Ther. 2023 Oct;12(5):2793-2800. doi: 10.1007/s40123-023-00756-3. Epub 2023 Jul 1.
- Individual participant dataSharing planned: Undecided. When published
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.
Jaime Tejedor, MD, PhD principal investigator
Universite Abdou Moumouni de Niamey, Niger
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraocular muscle stretching in people with Strabismus, Comitant, run by Universidad Autonoma de Madrid at 1 site in Spain.
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 1 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 3 May 2023. 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 Spain. 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?
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?
Distance deviation at 2 months after surgery (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778565, which also lists 1 linked publication.
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 3 May 2023.