Surgical CorrectionNCT07180199
Surgical Correction of V Pattern Intermittent Exotropia Without Inferior Oblique Muscle Overaction
A study testing Bilateral Lateral Rectus Recession (BLR Recession) and Bilateral Lateral Rectus Recession with Upward Transposition in people with Surgical Correction and V Pattern, run by Tanta University at 1 site in Egypt.
Trial summary
Evaluation of the results of surgical correction of V pattern intermittent exotropia without inferior oblique muscle overaction by either performing bilateral lateral rectus recession (BLR) alone or performing bilateral lateral rectus recession asssosiated with upward transposition of lateral rectus muscle insertion Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Correction, V Pattern, Intermittent Exotropia
- What is being tested?
- Bilateral Lateral Rectus Recession (BLR Recession) and Bilateral Lateral Rectus Recession with Upward Transposition
- 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
- 30 Aug 2023to 30 Aug 2024
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with V pattern intermittent exotropia (XT increasing by >10Δ in upgaze compared with Downgaze).
- No or minimal inferior oblique overaction on both sides (+1)
- Minimum follow-up period of 6 months after surgical correction of strabismus
Who cannot join
- Structural eye pathology.
- Significant neurodevelopmental delay.
- ntermittent exotropia without V pattern.
- Superior oblique under action.
- Duane syndrome.
- Less than 6 months follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Results of Surgical Correction of V Pattern Intermittent Exotropia Without Inferior Oblique Muscle Overaction
Evaluation of the results of surgical correction of V pattern intermittent exotropia without inferior oblique muscle overaction by either performing bilateral lateral rectus recession (BLR) alone or performing bilateral lateral rectus recession asssosiated with upward transposition of lateral rectus muscle insertion
Read the detailed description
Intermittent exotropia (IXT) is the most common type of strabismus which is a disorder of binocular eye movement control in which one eye intermittently moves outwards.Intermittent exotropia may be associated with difference in the horizontal deviation from the primary position to the upward or downward gaze giving A or V pattern In V-pattern intermittent exotropia (XT), there is an increase in the horizontal deviation as the eyes move from downgaze to upgaze.
Non-surgical treatment includes correction of refractive error, orthoptics, overcorrecting minus lenses and prismotherapy. Surgical options includes unilateral medial rectus muscle resection combined with a lateral rectus muscle recession or bilateral lateral rectus recession as in basic type IXT OR bilateral lateral rectus muscle recession as in divergent excess type OR bilateral medial rectus muscle resection as in convergence insufficiency.
- Conditions
- Surgical Correction, V Pattern, Intermittent Exotropia, Inferior Oblique Muscle, Overaction
- Being tested
- Bilateral Lateral Rectus Recession (BLR Recession), Bilateral Lateral Rectus Recession with Upward Transposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Lateral Rectus Recession (BLR Recession)Procedure or surgery
This procedure involved recession of both lateral rectus muscles to reduce large-angle exotropia.
Bilateral Lateral Rectus Recession with Upward TranspositionProcedure or surgery
This procedure involved bilateral lateral rectus recession combined with upward transposition of the insertion to enhance ocular alignment in patients with large-angle exotropia.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Lateral Rectus Recession (BLR Recession) | Experimental | Participants underwent bilateral lateral rectus recession procedure alone for correction of large-angle exotropia. Receives: Procedure: Bilateral Lateral Rectus Recession (BLR Recession) |
| Bilateral Lateral Rectus Recession with Upward Transposition | Experimental | Participants underwent bilateral lateral rectus recession combined with upward transposition of the muscle insertion to enhance alignment in cases of large-angle exotropia. Receives: Procedure: Bilateral Lateral Rectus Recession with Upward Transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of Ocular Deviation
The degree of ocular misalignment was measured using prism cover test at near and distance fixation. Successful outcome was defined as residual deviation ≤10 prism diopters.
Measured: 6 months postoperatively
Secondary outcomes (1)
Postoperative Complications
Complications such as overcorrection, undercorrection, or limitation of ocular motility were recorded.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Aug 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical CorrectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Abdelrahman Abdelwahab Oun, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180199
- Sponsor's protocol ID
- 36264MS244/7/23
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Results of Surgical Correction of V Pattern Intermittent Exotropia Without Inferior Oblique Muscle Overaction
- ClinicalTrials.gov ID
- NCT07180199
- Acronym / sponsor ID
- 36264MS244/7/23
- Conditions
- Surgical Correction, V Pattern, Intermittent Exotropia, Inferior Oblique Muscle, Overaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 18 Sep 2025 (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.
Evaluation of the results of surgical correction of V pattern intermittent exotropia without inferior oblique muscle overaction by either performing bilateral lateral rectus recession (BLR) alone or performing bilateral lateral rectus recession asssosiated with upward transposition of lateral rectus muscle insertion
Detailed description
Intermittent exotropia (IXT) is the most common type of strabismus which is a disorder of binocular eye movement control in which one eye intermittently moves outwards.Intermittent exotropia may be associated with difference in the horizontal deviation from the primary position to the upward or downward gaze giving A or V pattern In V-pattern intermittent exotropia (XT), there is an increase in the horizontal deviation as the eyes move from downgaze to upgaze.
Non-surgical treatment includes correction of refractive error, orthoptics, overcorrecting minus lenses and prismotherapy. Surgical options includes unilateral medial rectus muscle resection combined with a lateral rectus muscle recession or bilateral lateral rectus recession as in basic type IXT OR bilateral lateral rectus muscle recession as in divergent excess type OR bilateral medial rectus muscle resection as in convergence insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Lateral Rectus Recession (BLR Recession) | Experimental | Procedure: Bilateral Lateral Rectus Recession (BLR Recession)Participants underwent bilateral lateral rectus recession procedure alone for correction of large-angle exotropia. |
| Bilateral Lateral Rectus Recession with Upward Transposition | Experimental | Procedure: Bilateral Lateral Rectus Recession with Upward TranspositionParticipants underwent bilateral lateral rectus recession combined with upward transposition of the muscle insertion to enhance alignment in cases of large-angle exotropia. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with V pattern intermittent exotropia (XT increasing by >10Δ in upgaze compared with Downgaze).
- No or minimal inferior oblique overaction on both sides (+1)
- Minimum follow-up period of 6 months after surgical correction of strabismus
Key exclusion criteria (6 listed)
- Structural eye pathology.
- Significant neurodevelopmental delay.
- ntermittent exotropia without V pattern.
- Superior oblique under action.
- Duane syndrome.
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 Recession (BLR Recession)This procedure involved recession of both lateral rectus muscles to reduce large-angle exotropia. | Procedure or surgery | Bilateral Lateral Rectus Recession (BLR Recession) |
| Bilateral Lateral Rectus Recession with Upward TranspositionThis procedure involved bilateral lateral rectus recession combined with upward transposition of the insertion to enhance ocular alignment in patients with large-angle exotropia. | Procedure or surgery | Bilateral Lateral Rectus Recession with Upward Transposition |
Primary outcome
Angle of Ocular Deviation
Time frame: 6 months postoperatively
The degree of ocular misalignment was measured using prism cover test at near and distance fixation. Successful outcome was defined as residual deviation ≤10 prism diopters.
1 secondary outcome
Postoperative Complications
Time frame: 6 months postoperatively
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 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (BLR Recession) and Bilateral Lateral Rectus Recession with Upward Transposition in people with Surgical Correction and V Pattern, 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 6 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 Sep 2025. 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?
Angle of Ocular Deviation (time frame: 6 months postoperatively). 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 18 Sep 2025.