Intermittent ExotropiaIXTNCT05234957
Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance
A study testing Bilateral Lateral Rectus Recession in people with Intermittent Exotropia, run by Benha University at 1 site in Egypt.
Trial summary
The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Bilateral Lateral Rectus Recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Apr 2022to 18 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Basic-type intermittent exotropia
- Simulated distant-type intermittent exotropia
Who cannot join
- Alternating basic-type intermittent exotropia (no ocular dominance)
- Distant-type intermittent exotropia
- Convergence-insufficiency type intermittent exotropia
- Constant exotropia
- Sensory exotropia
- Deep amblyopia
- Paralytic or restrictive exotropia
- Previous extraocular muscle surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance
The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.
Read the detailed description
Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.
- Conditions
- Intermittent Exotropia
- Being tested
- Bilateral Lateral Rectus Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Lateral Rectus RecessionProcedure or surgery
Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. Receives: Procedure: Bilateral Lateral Rectus Recession |
| Group 2 | Active comparator | Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye. Receives: Procedure: Bilateral Lateral Rectus Recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Alignment at Distant Fixation
ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.
Measured: one year
Ocular Alignment at Near Fixation
ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.
Measured: one year
Secondary outcomes (2)
Sensory Status (Stereopsis)
ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.
Measured: one year
Sensory Status (Fusion)
Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start17 Apr 2022
- Primary completion18 Apr 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathy Farid, Benha University
- Investigators
- Mohamed Farid, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234957
- Sponsor's protocol ID
- RC1-1-2022
- Acronym
- IXT
- Status last verified
- Oct 2024
- First submitted
- 20 Jan 2022
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance
- ClinicalTrials.gov ID
- NCT05234957
- Acronym / sponsor ID
- IXT / RC1-1-2022
- Conditions
- Intermittent Exotropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.
Detailed description
Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Bilateral Lateral Rectus RecessionSymmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes. |
| Group 2 | Active comparator | Procedure: Bilateral Lateral Rectus RecessionAsymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Basic-type intermittent exotropia
- Simulated distant-type intermittent exotropia
Key exclusion criteria (8 listed)
- Alternating basic-type intermittent exotropia (no ocular dominance)
- Distant-type intermittent exotropia
- Convergence-insufficiency type intermittent exotropia
- Constant exotropia
- Sensory exotropia
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 |
|---|---|---|
| Bilateral Lateral Rectus RecessionSymmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Ocular Alignment at Distant Fixation
Time frame: one year
ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.
Ocular Alignment at Near Fixation
Time frame: one year
ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.
2 secondary outcomes
Sensory Status (Stereopsis)
Time frame: one year
Sensory Status (Fusion)
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Mohamed Farid, MD principal investigator
Benha 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 Bilateral Lateral Rectus Recession in people with Intermittent Exotropia, run by Benha 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 2 inclusion and 8 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 10 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ocular Alignment at Distant Fixation (time frame: one year). The study lists 2 primary outcomes in all. 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 10 Dec 2024.