StrabismusNCT04199286
Bilateral and Unilateral Horizontal Strabismus Surgery
A study testing symmetrical and asymmetrical horizontal strabismus surgery in people with Strabismus, run by Minia University at 2 sites in Egypt.
Trial summary
This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery Read more about this study
- Who is it for?
- Ages 4 to 28 years
- Conditions the study is for
- Strabismus
- What is being tested?
- symmetrical and asymmetrical horizontal strabismus surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Dec 2019to 14 Jun 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 4 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- more than 3 years old.
- alternating esotropia or exotropia
Who cannot join
- unilateral strabismus
- paralytic or restrictive strabismus
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine
Minya, Minya Governorate, 61111
Mohamed F K Ibrahiem
Minya, 61111
About this study
Official title: Assessment of Symmetrical and Asymmetrical Horizontal Strabismus Surgery: Efficacy and Lateral Incomitance
This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery
- Conditions
- Strabismus
- Being tested
- symmetrical and asymmetrical horizontal 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.
symmetrical and asymmetrical horizontal strabismus surgeryProcedure or surgery
surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye
| Study group | Role | What they receive |
|---|---|---|
| Asymmetrical surgery | Active comparator | This asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery Receives: Procedure: symmetrical and asymmetrical horizontal strabismus surgery |
| Symmetrical | Active comparator | This symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia Receives: Procedure: symmetrical and asymmetrical horizontal strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
There was 95% success rate in asymmetrical group compared with 90% in symmetrical one
This result was measured by simultaneous prism cover test and expressed in prism diopter
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start21 Dec 2019
- Primary completion1 Mar 2021
- Study completion14 Jun 2021
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199286
- Sponsor's protocol ID
- Minia University Hospital
- Status last verified
- Jun 2021
- First submitted
- 11 Dec 2019
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ismail AA, Abdelkader MF, Mohamed AA, Abdelaziz ST. Evaluation of Efficacy and Lateral Gaze Incomitance in Symmetrical and Asymmetrical Surgery for Concomitant Esotropia and Exotropia. Clin Ophthalmol. 2021 Aug 26;15:3613-3621. doi: 10.2147/OPTH.S326659. eCollection 2021.
PubMed 34471346
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Symmetrical and Asymmetrical Horizontal Strabismus Surgery: Efficacy and Lateral Incomitance
- ClinicalTrials.gov ID
- NCT04199286
- Acronym / sponsor ID
- Minia University Hospital
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 21 Dec 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 13 Dec 2019 (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.
This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymmetrical surgery | Active comparator | Procedure: symmetrical and asymmetrical horizontal strabismus surgeryThis asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery |
| Symmetrical | Active comparator | Procedure: symmetrical and asymmetrical horizontal strabismus surgeryThis symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia |
Who may qualify
- Ages
- 4 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- more than 3 years old.
- alternating esotropia or exotropia
Key exclusion criteria (2 listed)
- unilateral strabismus
- paralytic or 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 |
|---|---|---|
| symmetrical and asymmetrical horizontal strabismus surgerysurgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye | Procedure or surgery | Asymmetrical surgery, Symmetrical |
Primary outcome
There was 95% success rate in asymmetrical group compared with 90% in symmetrical one
Time frame: one and half year
This result was measured by simultaneous prism cover test and expressed in prism diopter
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 18 Jun 2021.
- Derived from this study: PubMed 34471346Ismail AA, Abdelkader MF, Mohamed AA, Abdelaziz ST. Evaluation of Efficacy and Lateral Gaze Incomitance in Symmetrical and Asymmetrical Surgery for Concomitant Esotropia and Exotropia. Clin Ophthalmol. 2021 Aug 26;15:3613-3621. doi: 10.2147/OPTH.S326659. eCollection 2021.
- Individual participant dataSharing planned: No
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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
Assistant professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symmetrical and asymmetrical horizontal strabismus surgery in people with Strabismus, run by Minia University at 2 sites 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 2 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 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
There was 95% success rate in asymmetrical group compared with 90% in symmetrical one (time frame: one and half year). 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 NCT04199286, 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 18 Jun 2021.