Strabismus, ComitantNCT04617158
Comparing Adjustable Sutures Surgery
A study testing Adjustable strabismus surgery in people with Strabismus, Comitant, run by Minia University at 1 site in Egypt.
Trial summary
Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Strabismus, Comitant
- What is being tested?
- Adjustable strabismus surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 10 Apr 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients
Who cannot join
- Patients with previous strabismus surgery Patients with oblique deviations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery
Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment
Read the detailed description
Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance
- Conditions
- Strabismus, Comitant
- Being tested
- Adjustable 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.
Adjustable strabismus surgeryProcedure or surgery
Adjustable surgery will be done using sliding nose technique using fornix approach
| Study group | Role | What they receive |
|---|---|---|
| Early adjustable suture surgery | Active comparator | Suture adjustment after 2 hours of surgery Receives: Procedure: Adjustable strabismus surgery |
| Late adjustable suture surgery | Active comparator | Suture adjustment after 24 hours of surgery Receives: Procedure: Adjustable strabismus surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alignment of the strabismus
Percentage of patients with successful postoperative alignment using prism cover test for measurement
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Dec 2019
- Primary completion20 Jan 2022
- Study completion10 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strabismus, ComitantStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar T A Abdelaziz, Minia University
- Investigators
- Sahar TA Abdelaziz, MD, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617158
- Sponsor's protocol ID
- Minia University 2020
- Status last verified
- Apr 2022
- First submitted
- 30 Oct 2020
- Last updated
- 25 Apr 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery
- ClinicalTrials.gov ID
- NCT04617158
- Acronym / sponsor ID
- Minia University 2020
- Conditions
- Strabismus, Comitant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 10 Apr 2022 (actual)
- First posted
- 5 Nov 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.
Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment
Detailed description
Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early adjustable suture surgery | Active comparator | Procedure: Adjustable strabismus surgerySuture adjustment after 2 hours of surgery |
| Late adjustable suture surgery | Active comparator | Procedure: Adjustable strabismus surgerySuture adjustment after 24 hours of surgery |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients
Key exclusion criteria (1 listed)
- Patients with previous strabismus surgery Patients with oblique deviations
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 |
|---|---|---|
| Adjustable strabismus surgeryAdjustable surgery will be done using sliding nose technique using fornix approach | Procedure or surgery | Early adjustable suture surgery, Late adjustable suture surgery |
Primary outcome
Alignment of the strabismus
Time frame: 3 months
Percentage of patients with successful postoperative alignment using prism cover test for measurement
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 25 Apr 2022.
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 Adjustable strabismus surgery in people with Strabismus, Comitant, 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 25 Apr 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?
Alignment of the strabismus (time frame: 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 25 Apr 2022.