Intermittent ExotropiaNCT06650735
Bilateral Lateral Rectus Recession Versus Bilateral Primary Medial Rectus Resection in Intermittent Exotropia
A study testing BMR resection and BLR recession in people with Intermittent Exotropia, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the efficacy of bilateral lateral rectus recession and bilateral primary medial rectus resection in basic type intermittent exotropia Participants will be randomized into two groups: bilateral lateral rectus (BLR) recession and bilateral medial rectus (BMR) resection… Read more about this study
- Who is it for?
- Ages 5 to 30 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- BMR resection and BLR 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
- 1 Jul 2023to Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with basic type intermittent exotropia
- Measurable angle 25-40 prism diopters
Who cannot join
- Restrictive or paralytic deviation or if forced duction test is positive on horizontal muscles
- Incomitant deviation, vertical or oblique muscles surgery and significant A or V pattern
- Previous strabismus, orbital or buckle surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Bilateral Lateral Rectus Recession and Bilateral Primary Medial Rectus Resection in Basic Type Intermittent Exotropia
The goal of this clinical trial is to compare the efficacy of bilateral lateral rectus recession and bilateral primary medial rectus resection in basic type intermittent exotropia
Participants will be randomized into two groups: bilateral lateral rectus (BLR) recession and bilateral medial rectus (BMR) resection groups then followed up in the clinic for 6 months to compare motor alignment and sensory functions
Read the detailed description
Study location: Cairo university hospitals
Methodology:
Patients with basic type intermittent exotropia who are indicated to undergo surgical intervention will be grouped into two groups one group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection.
- Preoperatively, all patients will be subjected to:
- A detailed history taking including presence of asthenopia, monocular closure, disfigurement or diplopia. The previous use of glasses for optical correction, use of minus lenses, or prior part time occlusion will be documented.
- A detailed ophthalmological examination; including uncorrected and best corrected visual acuity whenever possible, cycloplegic refraction, anterior segment examination and dilated fundus examination.
- Motor Evaluation:
- Ductions and versions will be done to assess the ocular motility in 9 positions of gaze.
- The angle of deviation will be measured by the alternate prism cover test for both distance (6 meters) and near (33 cm) , with and without glasses.
- The angles of misalignment will also be measured in side gazes and in straight up and down gaze whenever possible.
- In patients with near-far disparity, the angle of deviation will be measured again after patching one eye for 30 minutes, as well as after putting +3 D lenses in front of each eye. Patients with near-far disparity >10 prism diopters (PD) will not be included
- Sensory Evaluation: Worth 4 dot test and stereopsis using Random dot test (when possible) The control of exotropia will be assessed using both the newcastle control score Patients will be randomly assigned to either surgery using simple randomization by random number generator
- Intervention:
- One group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection according to the standard tables.
- All cases will be done under general anaesthesia.
- Both surgeries take about 30 minutes.
- Postoperative treatment combined tobramycin 0.3% and dexamethasone 0.1% eye drops 3 times daily and the same combination eye ointment at night for 3 weeks.
- Postoperative follow up will be 1 week, 6 weeks, 3 months and 6 months (minimum follow up)
- Postoperative assessment:
- Extraocular movement in lateral gazes will be examined for comitance
- Alignment in the primary position will be assessed and any deviation will be measured using alternate prism cover test
- Palpebral fissure height will be measured
- Worth 4 dot test and stereopsis will be assessed (when possible)
- In cases of failure either over correction or under correction reoperation will be performed after 3 months of the initial surgery.
- Sample size
We are planning a study of the difference in the postoperative angle between the 2 surgical techniques. Assuming a mean difference of 5 PD with a standard deviation of 5 PD, an alpha error of 0.05 and a power of study of 0.8, a total of 17 subjects were found to be needed in each group. Assuming a drop-out rate of 20%, a sample of 20 subjects will be targeted in each group.
- Conditions
- Intermittent Exotropia
- Being tested
- BMR resection, BLR recession
- Keywords
- IXT, lateral rectus recession, medial rectus resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMR resectionProcedure or surgery
Lid speculum will be applied. Fornix conjunctival incision will be used to expose medial rectus muscle. Area that will be resected will be marked using calipers. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle.
The muscle then excised anterior to the sutures and the stump cut flush to the sclera.
The muscle will be sutured again to the original insertion by scleral sutures which will be tied together.
Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl).
BLR recessionProcedure or surgery
Lid speculum will be applied. Fornix conjunctival incision will be used to expose lateral rectus muscle. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle close to the insertion.
The muscle will then be cut anterior to the sutures flush with the sclera. Calipers will used to mark the new insertion on sclera measured from the stump. The muscle will be sutured again to the new insertion by scleral sutures, which will be tied together.
Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl).
| Study group | Role | What they receive |
|---|---|---|
| BMR resection | Active comparator | Bilateral medial rectus muscle resection Receives: Procedure: BMR resection |
| BLR recession | Active comparator | Bilateral lateral rectus muscle recession Receives: Procedure: BLR recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor alignment in primary position
Success rate defined as orthophoria between exotropia/phoria ≤ to 8 prism diopters \& esotropia/phoria ≤ 4 prism diopters
Measured: 12 months
Secondary outcomes (3)
Palpebral fissure height
Change in palpebral fissure height in mm
Measured: 12 months
Lateral gaze comitance/incomitance
Difference between angles of deviation in right gaze, primary position, and left gaze
Measured: 12 months
Stereopsis
Change in stereoacuity in log seconds of arc
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Jul 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Awadein, Cairo University
- Investigators
- Yehia Salah Eldeen Mostafa, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650735
- Sponsor's protocol ID
- MD-328-2023
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Choi MY, Hwang JM. The long-term result of slanted medial rectus resection in exotropia of the convergence insufficiency type. Eye (Lond). 2006 Nov;20(11):1279-83. doi: 10.1038/sj.eye.6702095. Epub 2005 Sep 9.
PubMed 16151478Wang X, Zhang W, Chen B, Liao M, Liu L. Comparison of bilateral medial rectus plication and resection for the treatment of convergence insufficiency-type intermittent exotropia. Acta Ophthalmol. 2019 May;97(3):e448-e453. doi: 10.1111/aos.14056. Epub 2019 Feb 11.
PubMed 30740923Kushner BJ. Selective surgery for intermittent exotropia based on distance/near differences. Arch Ophthalmol. 1998 Mar;116(3):324-8. doi: 10.1001/archopht.116.3.324.
PubMed 9514485Pediatric Eye Disease Investigator Group; Writing Committee; Donahue SP, Chandler DL, Holmes JM, Arthur BW, Paysse EA, Wallace DK, Petersen DB, Melia BM, Kraker RT, Miller AM. A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia. Ophthalmology. 2019 Feb;126(2):305-317. doi: 10.1016/j.ophtha.2018.08.034. Epub 2018 Sep 3.
PubMed 30189281
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bilateral Lateral Rectus Recession and Bilateral Primary Medial Rectus Resection in Basic Type Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT06650735
- Acronym / sponsor ID
- MD-328-2023
- Conditions
- Intermittent Exotropia
- Keywords
- IXT, lateral rectus recession, medial rectus resection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 21 Oct 2024 (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.
The goal of this clinical trial is to compare the efficacy of bilateral lateral rectus recession and bilateral primary medial rectus resection in basic type intermittent exotropia
Participants will be randomized into two groups: bilateral lateral rectus (BLR) recession and bilateral medial rectus (BMR) resection groups then followed up in the clinic for 6 months to compare motor alignment and sensory functions
Detailed description
Study location: Cairo university hospitals
Methodology:
Patients with basic type intermittent exotropia who are indicated to undergo surgical intervention will be grouped into two groups one group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection.
- Preoperatively, all patients will be subjected to:
- A detailed history taking including presence of asthenopia, monocular closure, disfigurement or diplopia. The previous use of glasses for optical correction, use of minus lenses, or prior part time occlusion will be documented.
- A detailed ophthalmological examination; including uncorrected and best corrected visual acuity whenever possible, cycloplegic refraction, anterior segment examination and dilated fundus examination.
- Motor Evaluation:
- Ductions and versions will be done to assess the ocular motility in 9 positions of gaze.
- The angle of deviation will be measured by the alternate prism cover test for both distance (6 meters) and near (33 cm) , with and without glasses.
- The angles of misalignment will also be measured in side gazes and in straight up and down gaze whenever possible.
- In patients with near-far disparity, the angle of deviation will be measured again after patching one eye for 30 minutes, as well as after putting +3 D lenses in front of each eye. Patients with near-far disparity >10 prism diopters (PD) will not be included
- Sensory Evaluation: Worth 4 dot test and stereopsis using Random dot test (when possible) The control of exotropia will be assessed using both the newcastle control score Patients will be randomly assigned to either surgery using simple randomization by random number generator
- Intervention:
- One group will undergo bilateral lateral rectus recession and the other will undergo bilateral medial rectus resection according to the standard tables.
- All cases will be done under general anaesthesia.
- Both surgeries take about 30 minutes.
- Postoperative treatment combined tobramycin 0.3% and dexamethasone 0.1% eye drops 3 times daily and the same combination eye ointment at night for 3 weeks.
- Postoperative follow up will be 1 week, 6 weeks, 3 months and 6 months (minimum follow up)
- Postoperative assessment:
- Extraocular movement in lateral gazes will be examined for comitance
- Alignment in the primary position will be assessed and any deviation will be measured using alternate prism cover test
- Palpebral fissure height will be measured
- Worth 4 dot test and stereopsis will be assessed (when possible)
- In cases of failure either over correction or under correction reoperation will be performed after 3 months of the initial surgery.
- Sample size
We are planning a study of the difference in the postoperative angle between the 2 surgical techniques. Assuming a mean difference of 5 PD with a standard deviation of 5 PD, an alpha error of 0.05 and a power of study of 0.8, a total of 17 subjects were found to be needed in each group. Assuming a drop-out rate of 20%, a sample of 20 subjects will be targeted in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMR resection | Active comparator | Procedure: BMR resectionBilateral medial rectus muscle resection |
| BLR recession | Active comparator | Procedure: BLR recessionBilateral lateral rectus muscle recession |
Who may qualify
- Ages
- 5 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with basic type intermittent exotropia
- Measurable angle 25-40 prism diopters
Key exclusion criteria (3 listed)
- Restrictive or paralytic deviation or if forced duction test is positive on horizontal muscles
- Incomitant deviation, vertical or oblique muscles surgery and significant A or V pattern
- Previous strabismus, orbital or buckle surgery
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 |
|---|---|---|
| BMR resectionLid speculum will be applied. Fornix conjunctival incision will be used to expose medial rectus muscle. Area that will be resected will be marked using calipers. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle. The muscle then excised anterior to the sutures and the stump cut flush to the sclera. The muscle will be sutured again to the original insertion by scleral sutures which will be tied together. Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl). | Procedure or surgery | BMR resection |
| BLR recessionLid speculum will be applied. Fornix conjunctival incision will be used to expose lateral rectus muscle. Double-armed polyglactin 910 suture (6/0 Vicryl) will be used in securing the muscle close to the insertion. The muscle will then be cut anterior to the sutures flush with the sclera. Calipers will used to mark the new insertion on sclera measured from the stump. The muscle will be sutured again to the new insertion by scleral sutures, which will be tied together. Conjunctiva will be closed using polyglactin 910 suture (6/0 Vicryl). | Procedure or surgery | BLR recession |
Primary outcome
Motor alignment in primary position
Time frame: 12 months
Success rate defined as orthophoria between exotropia/phoria ≤ to 8 prism diopters \& esotropia/phoria ≤ 4 prism diopters
3 secondary outcomes
Palpebral fissure height
Time frame: 12 months
Lateral gaze comitance/incomitance
Time frame: 12 months
Stereopsis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Background: PubMed 16151478Choi MY, Hwang JM. The long-term result of slanted medial rectus resection in exotropia of the convergence insufficiency type. Eye (Lond). 2006 Nov;20(11):1279-83. doi: 10.1038/sj.eye.6702095. Epub 2005 Sep 9.
- Background: PubMed 30740923Wang X, Zhang W, Chen B, Liao M, Liu L. Comparison of bilateral medial rectus plication and resection for the treatment of convergence insufficiency-type intermittent exotropia. Acta Ophthalmol. 2019 May;97(3):e448-e453. doi: 10.1111/aos.14056. Epub 2019 Feb 11.
- Background: PubMed 9514485Kushner BJ. Selective surgery for intermittent exotropia based on distance/near differences. Arch Ophthalmol. 1998 Mar;116(3):324-8. doi: 10.1001/archopht.116.3.324.
- Background: PubMed 30189281Pediatric Eye Disease Investigator Group; Writing Committee; Donahue SP, Chandler DL, Holmes JM, Arthur BW, Paysse EA, Wallace DK, Petersen DB, Melia BM, Kraker RT, Miller AM. A Randomized Trial Comparing Bilateral Lateral Rectus Recession versus Unilateral Recess and Resect for Basic-Type Intermittent Exotropia. Ophthalmology. 2019 Feb;126(2):305-317. doi: 10.1016/j.ophtha.2018.08.034. Epub 2018 Sep 3.
- 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.
Yehia Salah Eldeen Mostafa, MD study chair
Cairo 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 BMR resection and BLR recession in people with Intermittent Exotropia, run by Cairo 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 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Motor alignment in primary position (time frame: 12 months). 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 NCT06650735, which also lists 4 linked publications.
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 21 Oct 2024; AzTrials last refreshed its copy on 1 Nov 2026.