ExotropiaNCT05089422
Study of Clinical Types and Surgical Out Come of Pediatric Exotropia
A study testing Squint surgery in people with Exotropia, run by Sohag University.
Trial summary
study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Exotropia
- What is being tested?
- Squint surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Jul 2022
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and children up to the age of 15 years.
- Primary Concomitant divergent squint (1ry concomitant exotropia)
- Candidate for surgical correction of squint
Who cannot join
- Children with:
- Paralytic squint
- Consecutive exotropia
- Any neurological disorder
- History of previous squint surgery
- History of previous other ocular surgery (e.g. congenital cataract \& glaucoma)
- Children who missed follow up.
About this study
Official title: Study of Clinical Types and Surgical Out Come of Pediatic Exotropia
study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital
Read the detailed description
A hospital-based, prospective, interventional study include infants and children up to the age of 15 years with Primary Concomitant divergent squint (1ry concomitant exotropia),Candidate for surgical correction of squint.
Each patient will be subjected to Detailed history and Full preoperative ophthalmic \& orthoptic evaluation including: Visual acuity , ocular motility in the 6 cardinal directions, Hirschberg test \& angle of deviation.
,Cover test \& prism cover test for distant \& near fixation,Cycloplegic refraction , Anterior segment examination, fundus examination.
_ post operative Follow-up regimen:
- Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively.
- The following will be recorded for each patient: Visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.
- Conditions
- Exotropia
- Being tested
- Squint surgery
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Squint surgeryProcedure or surgery
Lateral rectus recession and /or medial rectus resection
| Study group | Role | What they receive |
|---|---|---|
| Children with exotropia | Experimental | squint surgery Receives: Procedure: Squint surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of children who become corrected post operatively
Results of exotropia surgeries in children in sohag university hospital
Measured: Six months
The number of children with post operative residual squint
Results of exotropia surgeries in children in sohag university hospital
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExotropiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ali Hashim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089422
- Sponsor's protocol ID
- SAHashim
- Status last verified
- Oct 2021
- First submitted
- 5 Sep 2021
- Last updated
- 22 Oct 2021
- 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 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Clinical Types and Surgical Out Come of Pediatic Exotropia
- ClinicalTrials.gov ID
- NCT05089422
- Acronym / sponsor ID
- SAHashim
- Conditions
- Exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 22 Oct 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.
study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital
Detailed description
A hospital-based, prospective, interventional study include infants and children up to the age of 15 years with Primary Concomitant divergent squint (1ry concomitant exotropia),Candidate for surgical correction of squint.
Each patient will be subjected to Detailed history and Full preoperative ophthalmic \& orthoptic evaluation including: Visual acuity , ocular motility in the 6 cardinal directions, Hirschberg test \& angle of deviation.
,Cover test \& prism cover test for distant \& near fixation,Cycloplegic refraction , Anterior segment examination, fundus examination.
_ post operative Follow-up regimen:
- Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively.
- The following will be recorded for each patient: Visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with exotropia | Experimental | Procedure: Squint surgerysquint surgery |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants and children up to the age of 15 years.
- Primary Concomitant divergent squint (1ry concomitant exotropia)
- Candidate for surgical correction of squint
Key exclusion criteria (7 listed)
- Children with:
- Children who missed follow up.
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 |
|---|---|---|
| Squint surgeryLateral rectus recession and /or medial rectus resection | Procedure or surgery | Children with exotropia |
Primary outcome
The number of children who become corrected post operatively
Time frame: Six months
Results of exotropia surgeries in children in sohag university hospital
The number of children with post operative residual squint
Time frame: Six months
Results of exotropia surgeries in children in sohag university hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Squint surgery in people with Exotropia, run by Sohag University.
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 7 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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The number of children who become corrected post operatively (time frame: Six months). The study lists 2 primary outcomes in all. 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 22 Oct 2021.