StrabismusNCT04285177
Choroidal and Retinal Thickness Following Strabismus Surgery
An observational study of Strabismus and Retinal Thickening, run by Tanta University at 1 site in Egypt.
Trial summary
Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery Read more about this study
- Who is it for?
- Ages 7 to 40 years
- Conditions the study is for
- Strabismus, Retinal Thickening
- What is being tested?
- Strabismus surgery
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2020to Dec 2020
- Phase
- Observational
- 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 7 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All individual with strabismus fulfilling the inclusion criteria
Who may be able to join
- No prior history of ocular surgery or trauma
- Normal ocular examination findings
- No medical or family history of retinal disease, glaucoma or diabetes mellitus.
Who cannot join
- Patients with orbital and/or craniofacial abnormalities
- Patients with sensory or restrictive strabismus or neurological disease
- Preoperative retinal or macular pathology
- Patient who is unable to cooperate to do OCT scanning
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography
Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery
Read the detailed description
This is a prospective study and will be conducted in Tanta University hospital
- Duration: February 2020 till May 2020 and may be extended
- The study will include 30 patients who suffer from esotropia or exotropia, inferior oblique (IO) over-action with or without any other type of horizontal deviation
Pre-operative measurement of the macular and choroidal thickness by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT).
Post-operative measurement: First day, first week, one month then 3 months.
- Conditions
- Strabismus, Retinal Thickening
- 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
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy
| Study group | Role | What they receive |
|---|---|---|
| Horizontal muscle surgery | Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection Receives: Procedure: Strabismus surgery | |
| Patients with Inferior Oblique Overaction | Will undergo inferior Oblique Myectomy Receives: Procedure: Strabismus surgery | |
| Patients with combined horizontal and oblique muscle surgery | Having combined surgery Receives: Procedure: Strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal and retinal thickness change after strabismus surgery
Measured by Spectral Domain Optical coherence tomography
Measured: preoperative, 1st week, 1st month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start15 Feb 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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.
- More trials run by Tanta 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Shafik, Tanta University
- Investigators
- Sharif Y El Emam, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285177
- Sponsor's protocol ID
- TUORU003
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04285177
- Acronym / sponsor ID
- TUORU003
- Conditions
- Strabismus, Retinal Thickening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Feb 2020 (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.
Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery
Detailed description
This is a prospective study and will be conducted in Tanta University hospital
- Duration: February 2020 till May 2020 and may be extended
- The study will include 30 patients who suffer from esotropia or exotropia, inferior oblique (IO) over-action with or without any other type of horizontal deviation
Pre-operative measurement of the macular and choroidal thickness by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT).
Post-operative measurement: First day, first week, one month then 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Horizontal muscle surgery | – | Procedure: Strabismus surgeryPatients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection |
| Patients with Inferior Oblique Overaction | – | Procedure: Strabismus surgeryWill undergo inferior Oblique Myectomy |
| Patients with combined horizontal and oblique muscle surgery | – | Procedure: Strabismus surgeryHaving combined surgery |
Who may qualify
- Ages
- 7 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All individual with strabismus fulfilling the inclusion criteria
Key inclusion criteria (3 listed)
- No prior history of ocular surgery or trauma
- Normal ocular examination findings
- No medical or family history of retinal disease, glaucoma or diabetes mellitus.
Key exclusion criteria (4 listed)
- Patients with orbital and/or craniofacial abnormalities
- Patients with sensory or restrictive strabismus or neurological disease
- Preoperative retinal or macular pathology
- Patient who is unable to cooperate to do OCT scanning
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 surgeryResection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy | Procedure or surgery | Horizontal muscle surgery, Patients with Inferior Oblique Overaction, Patients with combined horizontal and oblique muscle surgery |
Primary outcome
Choroidal and retinal thickness change after strabismus surgery
Time frame: preoperative, 1st week, 1st month, and 3 months
Measured by Spectral Domain Optical coherence tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- 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.
Sharif Y El Emam, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strabismus and Retinal Thickening, run by Tanta 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 4 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 26 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?
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?
Choroidal and retinal thickness change after strabismus surgery (time frame: preoperative, 1st week, 1st month, and 3 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 Feb 2020.