StrabismusNCT04961021
Management of Consecutive Exotropia
A study testing Strabismus surgery in people with Strabismus and Concomitant Squint, run by Minia University at 1 site in Egypt.
Trial summary
Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Strabismus, Concomitant Squint, Divergent 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
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2020to 31 Dec 2021
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with consecutive exotropia.
- Eight years old or more.
- Cooperative patients.
Who cannot join
- Adduction deficit.
- Mental disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Consecutive Exotropia and Its Effect on Ocular Motility
Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession
- Conditions
- Strabismus, Concomitant Squint, Divergent Strabismus
- Being tested
- Strabismus surgery
- Medical subject headings
- Strabismus, Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strabismus surgeryProcedure or surgery
Strengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle
| Study group | Role | What they receive |
|---|---|---|
| Medial rectus advancement with resection | Active comparator | Surgery will be done to strengthen the medial rectus muscle with resection and anterior displacement again to the original insertion site 5 mm from limbus Receives: Procedure: Strabismus surgery |
| Medial rectus advancement with lateral rectus recession | Active comparator | Surgery will be done to strengthen the medial rectus muscle with anterior displacement again to the original insertion site 4- 5 mm from limbus with weakening procedure to the lateral rectus muscle at the same time Receives: Procedure: Strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with satisfactory postoperative alignment
Efficacy of each surgical procedure and its further effect using prism cover test to access postoperative alignment of the eye
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 posted14 Jul 2021
- Study start3 Aug 2020
- Primary completion30 Oct 2021
- Study completion31 Dec 2021
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- Sahar TA Abdelaziz, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961021
- Sponsor's protocol ID
- Strabismus
- Status last verified
- Jan 2022
- First submitted
- 9 Jul 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Consecutive Exotropia and Its Effect on Ocular Motility
- ClinicalTrials.gov ID
- NCT04961021
- Acronym / sponsor ID
- Strabismus
- Conditions
- Strabismus, Concomitant Squint, Divergent Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jul 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.
Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial rectus advancement with resection | Active comparator | Procedure: Strabismus surgerySurgery will be done to strengthen the medial rectus muscle with resection and anterior displacement again to the original insertion site 5 mm from limbus |
| Medial rectus advancement with lateral rectus recession | Active comparator | Procedure: Strabismus surgerySurgery will be done to strengthen the medial rectus muscle with anterior displacement again to the original insertion site 4- 5 mm from limbus with weakening procedure to the lateral rectus muscle at the same time |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with consecutive exotropia.
- Eight years old or more.
- Cooperative patients.
Key exclusion criteria (2 listed)
- Adduction deficit.
- Mental disability.
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 surgeryStrengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle | Procedure or surgery | Medial rectus advancement with lateral rectus recession, Medial rectus advancement with resection |
Primary outcome
Percentage of patients with satisfactory postoperative alignment
Time frame: 6 months
Efficacy of each surgical procedure and its further effect using prism cover test to access postoperative alignment of the eye
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 26 Jan 2022.
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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.
Sahar TA Abdelaziz, 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 and Concomitant Squint, 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 3 inclusion and 2 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 26 Jan 2022. 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?
Percentage of patients with satisfactory postoperative alignment (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 26 Jan 2022.