StrabismusNCT03153423
Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction
A study testing Strabismus surgery in people with Strabismus, run by Minia University at 1 site in Egypt.
Trial summary
To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex Read more about this study
- Who is it for?
- Ages 3 to 25 years
- Conditions the study is for
- Strabismus
- What is being tested?
- Strabismus surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2017to 14 Jan 2020
- 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 3 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Basic type intermittent exotropia
Who cannot join
- previous strabismus surgery restrictive strabismus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basic Intermittent Exotropia; is the Axial Length of the Globe One of the Prognostic Factors for Overcorrection and Undercorrection After Binocular Surgery
To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex
- Conditions
- Strabismus
- Being tested
- Strabismus surgery
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strabismus surgeryProcedure or surgery
Recession and resection of horizontal extra ocular muscles
| Study group | Role | What they receive |
|---|---|---|
| Basic intermittent exotropia patients | Other | Not described Receives: Procedure: Strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors for postoperative overcorrections and under corrections
as axial length of the globe, age, sex and refractive error
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 posted15 May 2017
- Study start5 Aug 2017
- Primary completion20 Dec 2019
- Study completion14 Jan 2020
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.
- 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
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Farag Khalil Ibrahiem, Minia University
- Investigators
- Mohamed F Ibrahiem, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153423
- Sponsor's protocol ID
- Minia2017
- Status last verified
- Feb 2020
- First submitted
- 11 May 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basic Intermittent Exotropia; is the Axial Length of the Globe One of the Prognostic Factors for Overcorrection and Undercorrection After Binocular Surgery
- ClinicalTrials.gov ID
- NCT03153423
- Acronym / sponsor ID
- Minia2017
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 5 Aug 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 15 May 2017 (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.
To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic intermittent exotropia patients | Other | Procedure: Strabismus surgery |
Who may qualify
- Ages
- 3 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Basic type intermittent exotropia
Key exclusion criteria (1 listed)
- previous strabismus surgery restrictive strabismus
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 |
|---|---|---|
| Strabismus surgeryRecession and resection of horizontal extra ocular muscles | Procedure or surgery | Basic intermittent exotropia patients |
Primary outcome
Risk factors for postoperative overcorrections and under corrections
Time frame: 6 months
as axial length of the globe, age, sex and refractive error
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 20 Feb 2020.
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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.
Mohamed F Ibrahiem, MD principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strabismus surgery in people with Strabismus, run by Minia 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 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
Risk factors for postoperative overcorrections and under corrections (time frame: 6 months). 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 20 Feb 2020.