Infantile EsotropiaNCT06221098
Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital
A study testing bilateral medial rectus recession in people with Infantile Esotropia, run by Sohag University at 1 site in Egypt.
Trial summary
Strabismus (or squint) is defined as the presence of misalignment between the visual axes of the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into comitant (if the amount of misalignment between the 2 eyes remained equal in all directions of gaze) and incomitant (if the amount of… Read more about this study
- Who is it for?
- Ages 1 day to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Infantile Esotropia
- What is being tested?
- bilateral medial rectus recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Oct 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 1 day to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants and children up to the age of 12 years.
- Primary Concomitant convergent squint (1ry concomitant esotropia)
- Candidate for surgical correction of squint
Who cannot join
- 1. Children with:
- Paralytic squint
- Consecutive esotropia
- Any neurological disorders e.g. hydrocephalus.
- History of previous squint surgery
- History of previous other ocular surgery (e.g. congenital cataract \& glaucoma) 2. Children who missed follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Strabismus (or squint) is defined as the presence of misalignment between the visual axes of the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into comitant (if the amount of misalignment between the 2 eyes remained equal in all directions of gaze) and incomitant (if the amount of misalignment varied in different directions of gaze). If the squinting eye was deviated inward, it is termed as a convergent squint or esotropia and if the squinting eye is deviated outward, it is termed as a divergent squint or exotropia. Pediatric esotropia may be congenital or acquired. Congenital esotropia is a well-defined entity with an onset prior to 6 months of age, characterised by a large stable angle, cross fixation, and a limited potential for binocular single vision. Acquired childhood esotropia may be paralytic or non-paralytic. The non-paralytic or concomitant type, which is neither congenital nor secondary to ocular pathology, can be divided into three main groups: (1) Accommodative esotropia, which may be fully accommodative, partially accommodative, or accommodative with convergence excess; (2) Non-accommodative esotropia; (3) Esotropia associated with neurological dysfunction, in particular cerebral palsy and hydrocephalus. The last group of esotropia will be excluded from our study. Pediatric strabismus must be treated early to maximize the potential for binocular vision and decrease the risk of amblyopia. Treatment goals include good vision in each eye (no amblyopia) and straight eyes (orthotropia). Both conditions are necessary to produce stereopsis, which is a third goal. Strabismus in children may result in undesirable appearance, amblyopia, impaired stereopsis, diplopia, and negative psychological effect.
- Conditions
- Infantile Esotropia
- Being tested
- bilateral medial rectus recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral medial rectus recessionProcedure or surgery
Also called Monocular medial rectus (MR) recession and lateral rectus (LR) resection
release muuscle from its original insertion and backword inserted in sclera
| Study group | Role | What they receive |
|---|---|---|
| congenital esotropia | Active comparator | will be defined as that type of esotropia with an onset prior to 6 months of age \& characterized by a large stable angle Receives: Procedure: bilateral medial rectus recession |
| accommodative esotropia | Active comparator | Fully accommodative esotropia will be defined as an esotropia which is controlled for distance and near with full hypermetropic correction. Partially accommodative esotropia will be defined as a reduction in the angle of esotropia of 10 dioptres or more for distance or near, using the full hypermetropic correctionAccommodative esotropia with convergence excess occurs when the near angle exceeded the distance angle by 15 dioptres or more when fixating an accommodative target, using the full hypermetropic correction. Receives: Procedure: bilateral medial rectus recession |
| non-accommodative esotropia | Active comparator | neither congenital nor accommodative esotropia Receives: Procedure: bilateral medial rectus recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
orthotropia
eye alignment
Measured: 6 months
residual esotropia
esotropia >10PD undercorrection
Measured: 6months
consecuative exotropia
exotropia > 10PD overcorrection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infantile EsotropiaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Nasser Mazen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221098
- Sponsor's protocol ID
- soh-med-22-04-03
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mohney BG. Common forms of childhood strabismus in an incidence cohort. Am J Ophthalmol. 2007 Sep;144(3):465-7. doi: 10.1016/j.ajo.2007.06.011.
PubMed 17765436Rubin SE, Nelson LB, Wagner RS, Simon JW, Catalano RA. Infantile exotropia in healthy children. Ophthalmic Surg. 1988 Nov;19(11):792-4. doi: 10.3928/0090-4481-19881101-07.
PubMed 3222041von Noorden GK. Bowman lecture. Current concepts of infantile esotropia. Eye (Lond). 1988;2 ( Pt 4):343-57. doi: 10.1038/eye.1988.65.
PubMed 3075563Mulvihill A, MacCann A, Flitcroft I, O'Keefe M. Outcome in refractive accommodative esotropia. Br J Ophthalmol. 2000 Jul;84(7):746-9. doi: 10.1136/bjo.84.7.746.
PubMed 10873987
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Types and Treatment Outcomes of Pediatric Esotropia in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06221098
- Acronym / sponsor ID
- soh-med-22-04-03
- Conditions
- Infantile Esotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 24 Jan 2024 (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.
Strabismus (or squint) is defined as the presence of misalignment between the visual axes of the 2 eyes presenting with deviation of the eyes. Strabismus is further subdivided into comitant (if the amount of misalignment between the 2 eyes remained equal in all directions of gaze) and incomitant (if the amount of misalignment varied in different directions of gaze). If the squinting eye was deviated inward, it is termed as a convergent squint or esotropia and if the squinting eye is deviated outward, it is termed as a divergent squint or exotropia. Pediatric esotropia may be congenital or acquired. Congenital esotropia is a well-defined entity with an onset prior to 6 months of age, characterised by a large stable angle, cross fixation, and a limited potential for binocular single vision. Acquired childhood esotropia may be paralytic or non-paralytic. The non-paralytic or concomitant type, which is neither congenital nor secondary to ocular pathology, can be divided into three main groups: (1) Accommodative esotropia, which may be fully accommodative, partially accommodative, or accommodative with convergence excess; (2) Non-accommodative esotropia; (3) Esotropia associated with neurological dysfunction, in particular cerebral palsy and hydrocephalus. The last group of esotropia will be excluded from our study. Pediatric strabismus must be treated early to maximize the potential for binocular vision and decrease the risk of amblyopia. Treatment goals include good vision in each eye (no amblyopia) and straight eyes (orthotropia). Both conditions are necessary to produce stereopsis, which is a third goal. Strabismus in children may result in undesirable appearance, amblyopia, impaired stereopsis, diplopia, and negative psychological effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| congenital esotropia | Active comparator | Procedure: bilateral medial rectus recessionwill be defined as that type of esotropia with an onset prior to 6 months of age \& characterized by a large stable angle |
| accommodative esotropia | Active comparator | Procedure: bilateral medial rectus recessionFully accommodative esotropia will be defined as an esotropia which is controlled for distance and near with full hypermetropic correction. Partially accommodative esotropia will be defined as a reduction in the angle of esotropia of 10 dioptres or more for distance or near, using the full hypermetropic correctionAccommodative esotropia with convergence excess occurs when the near angle exceeded the distance angle by 15 dioptres or more when fixating an accommodative target, using the full hypermetropic correction. |
| non-accommodative esotropia | Active comparator | Procedure: bilateral medial rectus recessionneither congenital nor accommodative esotropia |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants and children up to the age of 12 years.
- Primary Concomitant convergent squint (1ry concomitant esotropia)
- Candidate for surgical correction of squint
Key exclusion criteria (6 listed)
- 1. Children with:
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 |
|---|---|---|
| bilateral medial rectus recessionAlso: Monocular medial rectus (MR) recession and lateral rectus (LR) resectionrelease muuscle from its original insertion and backword inserted in sclera | Procedure or surgery | accommodative esotropia, congenital esotropia, non-accommodative esotropia |
Primary outcome
orthotropia
Time frame: 6 months
eye alignment
residual esotropia
Time frame: 6months
esotropia >10PD undercorrection
consecuative exotropia
Time frame: 6 months
exotropia > 10PD overcorrection
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 24 Jan 2024.
- Background: PubMed 17765436Mohney BG. Common forms of childhood strabismus in an incidence cohort. Am J Ophthalmol. 2007 Sep;144(3):465-7. doi: 10.1016/j.ajo.2007.06.011.
- Background: PubMed 3222041Rubin SE, Nelson LB, Wagner RS, Simon JW, Catalano RA. Infantile exotropia in healthy children. Ophthalmic Surg. 1988 Nov;19(11):792-4. doi: 10.3928/0090-4481-19881101-07.
- Background: PubMed 3075563von Noorden GK. Bowman lecture. Current concepts of infantile esotropia. Eye (Lond). 1988;2 ( Pt 4):343-57. doi: 10.1038/eye.1988.65.
- Background: PubMed 10873987Mulvihill A, MacCann A, Flitcroft I, O'Keefe M. Outcome in refractive accommodative esotropia. Br J Ophthalmol. 2000 Jul;84(7):746-9. doi: 10.1136/bjo.84.7.746.
- Individual participant dataSharing planned: Undecided
Related trials for Infantile Esotropia
Active, not recruitingObservational study
An Observational Cohort Study to Explore the Clinical Outcome of Congenital Strabismmus Based on Etiology and Timing of Surgery
Congenital Esotropia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral medial rectus recession in people with Infantile Esotropia, run by Sohag University at 1 site in Egypt.
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 6 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 24 Jan 2024. 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 Egypt. 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?
orthotropia (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT06221098, which also lists 4 linked publications.
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 24 Jan 2024.