Intermittent ExotropiaNCT04307160
Relationship of Age at Surgery to Surgical Outcome After Surgery for Intermittent Exotropia
An observational study of Intermittent Exotropia, run by Cairo University.
Trial summary
It is prospective cohort study to compare ( the surgical outcome) the motor and sensory outcome of early surgery (≤5 years of age) and late surgery ( ≥ 7 years of age) for intermittent exotropia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Bilateral lateral rectus recession
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 30 Jun 2022
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: One hundred and twenty four patients with intermittent exotropia will be included in this study in form of two groups based on the age at the first surgery; each group including 62 patients * Group I patients ≤ 5 years of age * Group II patients ≥ 7 years of age Patients will be recruited from Kasr El Ainy and Cairo University Children Hospitals
Who may be able to join
- All patients with intermittent exotropia in whom surgery is indicated
Who cannot join
- Patients with prior eye muscle surgery, restrictive or paralytic strabismus will be excluded. In addition, patients with craniofacial anomalies or neurological problems
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Age at Time of Surgery on the Surgical Outcome After Bilateral Lateral Rectus Muscle Recession in Intermittent Exotropia
It is prospective cohort study to compare ( the surgical outcome) the motor and sensory outcome of early surgery (≤5 years of age) and late surgery ( ≥ 7 years of age) for intermittent exotropia.
Read the detailed description
Sample Size:
One hundred and twenty four patients with intermittent exotropia will be included in this study in form of two groups based on the age at the first surgery; each group including 62 patients
- Group I patients ≤ 5 years of age
- Group II patients ≥ 7 years of age
Sample size calculation:
We are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the success rate among adults is 0.75. If the success rate for the young age group is 0.5, we will need to study 58 adult subjects and 58 young subjects to be able to reject the null hypothesis that the success rates for young and adult subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. Assuming a dropout rate of 5 %, a total of 62 patients will be recruited in each group.
Inclusion criteria:
All patients with intermittent exotropia in whom surgery is indicated
Exclusion criteria:
Patients with prior eye muscle surgery, restrictive or paralytic strabismus will be excluded. In addition, patients with craniofacial anomalies or neurological problems will be excluded from the study.
Methodology (in details):
A detailed history will be obtained 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 corrected and uncorrected visual acuity whenever feasible, cycloplegic refraction, anterior segment examination and dilated fundus examination for any abnormalities.
Motor Evaluation:
Ductions and versions will be done to assess the ocular motility in all diagnositic positions of gaze.
The angle of misalignment will be measured by the prism and alternate cover tests for both distance and near. The angle will be measured without and with 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 distance 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.
The control of exotropia will be assessed using both the newcastle control score and the new intermittent exotropia control scale designed by Mohney and Holmes.
Sensory Evaluation:
TNO stereo test, titmus fly test and worth 4 dot test for far will be done whenever possible.
Surgery:
All patients will undergo bilateral lateral rectus recession according to standard tables. In the younger age group, the amount of lateral rectus recession will be reduced by 0.5 mm. in those with inferior oblique overaction, inferior oblique recession will be performed.
Follow up and Evaluation:
Postoperatively, patients will be examined in the same preoperative manner after one week then after 6 weeks, 3 month and 6 months to assess the horizontal alignment and do sensory evaluation whenever possible.
Statistical analysis:
Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) version (21). Median and range for non-parametric measures and ordinal (scores) data. Numerical data will be presented as means ± standard deviations (SD). Categorical data will be presented as number and percentages %. Pairwise comparisons between the two groups for normally distributed variables will be done using the Student's t-test; the Mann-Whitney test, a nonparametric test equivalent to the t-test, will be used in non-normally distributed variables. The pre and postoperative data will be compared using repeated measures ANOVA, with Friedman's test as its non-parametric equivalent. The chi-square test or the Fisher's exact test will be used to compare between the groups with respect to categorical data. All p-values will be two-sided. P-values < 0.05 will be considered significant.
- 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
All patients will undergo bilateral lateral rectus recession according to standard tables. In the younger age group, the amount of lateral rectus recession will be reduced by 0.5 mm. in those with inferior oblique overaction, inferior oblique recession will be performed
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients ≤ 5 years of age Receives: Procedure: Bilateral lateral rectus recession | |
| Group II | Patients ≥ 7 years of age Receives: Procedure: Bilateral lateral rectus recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor success rate
Success rate defined as deviation between exotropia/phoria of 8 PD to esotropia/phoria of 4 PD
Measured: Six months
Secondary outcomes (3)
Change in stereoacuity
Average log improvement of stereoacuity using TNO test at 6 months
Measured: Six months
New misalignment
Number of patients who developed underaction, or overaction of horizontal or oblique muscles
Measured: Six months
Pattern deviation
Number of patient who develop new A or V pattern after surgery.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Awadein, Cairo University
- Investigators
- Ayman Elshiaty, MD, Study director, Head of Ophthalmology Department, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307160
- Sponsor's protocol ID
- D-31-2019
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Buck D, Powell CJ, Sloper JJ, Taylor R, Tiffin P, Clarke MP; Improving Outcomes in Intermittent Exotropia (IOXT) Study group. Surgical intervention in childhood intermittent exotropia: current practice and clinical outcomes from an observational cohort study. Br J Ophthalmol. 2012 Oct;96(10):1291-5. doi: 10.1136/bjophthalmol-2012-301981. Epub 2012 Aug 11.
PubMed 22887975Richard JM, Parks MM. Intermittent exotropia. Surgical results in different age groups. Ophthalmology. 1983 Oct;90(10):1172-7.
PubMed 6657192Pratt-Johnson JA, Barlow JM, Tillson G. Early surgery in intermittent exotropia. Am J Ophthalmol. 1977 Nov;84(5):689-94. doi: 10.1016/0002-9394(77)90385-3. No abstract available.
PubMed 930997Haggerty H, Richardson S, Hrisos S, Strong NP, Clarke MP. The Newcastle Control Score: a new method of grading the severity of intermittent distance exotropia. Br J Ophthalmol. 2004 Feb;88(2):233-5. doi: 10.1136/bjo.2003.027615.
PubMed 14736781Abroms AD, Mohney BG, Rush DP, Parks MM, Tong PY. Timely surgery in intermittent and constant exotropia for superior sensory outcome. Am J Ophthalmol. 2001 Jan;131(1):111-6. doi: 10.1016/s0002-9394(00)00623-1.
PubMed 11162985Choi J, Kim SJ, Yu YS. Initial postoperative deviation as a predictor of long-term outcome after surgery for intermittent exotropia. J AAPOS. 2011 Jun;15(3):224-9. doi: 10.1016/j.jaapos.2010.12.019. Epub 2011 Jun 12.
PubMed 21665502
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age at Time of Surgery on the Surgical Outcome After Bilateral Lateral Rectus Muscle Recession in Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT04307160
- Acronym / sponsor ID
- D-31-2019
- Conditions
- Intermittent Exotropia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 13 Mar 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.
It is prospective cohort study to compare ( the surgical outcome) the motor and sensory outcome of early surgery (≤5 years of age) and late surgery ( ≥ 7 years of age) for intermittent exotropia.
Detailed description
Sample Size:
One hundred and twenty four patients with intermittent exotropia will be included in this study in form of two groups based on the age at the first surgery; each group including 62 patients
- Group I patients ≤ 5 years of age
- Group II patients ≥ 7 years of age
Sample size calculation:
We are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the success rate among adults is 0.75. If the success rate for the young age group is 0.5, we will need to study 58 adult subjects and 58 young subjects to be able to reject the null hypothesis that the success rates for young and adult subjects are equal with probability (power) 0.8. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use an uncorrected chi-squared statistic to evaluate this null hypothesis. Assuming a dropout rate of 5 %, a total of 62 patients will be recruited in each group.
Inclusion criteria:
All patients with intermittent exotropia in whom surgery is indicated
Exclusion criteria:
Patients with prior eye muscle surgery, restrictive or paralytic strabismus will be excluded. In addition, patients with craniofacial anomalies or neurological problems will be excluded from the study.
Methodology (in details):
A detailed history will be obtained 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 corrected and uncorrected visual acuity whenever feasible, cycloplegic refraction, anterior segment examination and dilated fundus examination for any abnormalities.
Motor Evaluation:
Ductions and versions will be done to assess the ocular motility in all diagnositic positions of gaze.
The angle of misalignment will be measured by the prism and alternate cover tests for both distance and near. The angle will be measured without and with 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 distance 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.
The control of exotropia will be assessed using both the newcastle control score and the new intermittent exotropia control scale designed by Mohney and Holmes.
Sensory Evaluation:
TNO stereo test, titmus fly test and worth 4 dot test for far will be done whenever possible.
Surgery:
All patients will undergo bilateral lateral rectus recession according to standard tables. In the younger age group, the amount of lateral rectus recession will be reduced by 0.5 mm. in those with inferior oblique overaction, inferior oblique recession will be performed.
Follow up and Evaluation:
Postoperatively, patients will be examined in the same preoperative manner after one week then after 6 weeks, 3 month and 6 months to assess the horizontal alignment and do sensory evaluation whenever possible.
Statistical analysis:
Data management and analysis will be performed using Statistical Package for Social Sciences (SPSS) version (21). Median and range for non-parametric measures and ordinal (scores) data. Numerical data will be presented as means ± standard deviations (SD). Categorical data will be presented as number and percentages %. Pairwise comparisons between the two groups for normally distributed variables will be done using the Student's t-test; the Mann-Whitney test, a nonparametric test equivalent to the t-test, will be used in non-normally distributed variables. The pre and postoperative data will be compared using repeated measures ANOVA, with Friedman's test as its non-parametric equivalent. The chi-square test or the Fisher's exact test will be used to compare between the groups with respect to categorical data. All p-values will be two-sided. P-values < 0.05 will be considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Procedure: Bilateral lateral rectus recessionPatients ≤ 5 years of age |
| Group II | – | Procedure: Bilateral lateral rectus recessionPatients ≥ 7 years of age |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- One hundred and twenty four patients with intermittent exotropia will be included in this study in form of two groups based on the age at the first surgery; each group including 62 patients * Group I patients ≤ 5 years of age * Group II patients ≥ 7 years of age Patients will be recruited from Kasr El Ainy and Cairo University Children Hospitals
Key inclusion criteria (1 listed)
- All patients with intermittent exotropia in whom surgery is indicated
Key exclusion criteria (1 listed)
- Patients with prior eye muscle surgery, restrictive or paralytic strabismus will be excluded. In addition, patients with craniofacial anomalies or neurological problems
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 recessionAll patients will undergo bilateral lateral rectus recession according to standard tables. In the younger age group, the amount of lateral rectus recession will be reduced by 0.5 mm. in those with inferior oblique overaction, inferior oblique recession will be performed | Procedure or surgery | Group I, Group II |
Primary outcome
Motor success rate
Time frame: Six months
Success rate defined as deviation between exotropia/phoria of 8 PD to esotropia/phoria of 4 PD
3 secondary outcomes
Change in stereoacuity
Time frame: Six months
New misalignment
Time frame: Six months
Pattern deviation
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Background: PubMed 22887975Buck D, Powell CJ, Sloper JJ, Taylor R, Tiffin P, Clarke MP; Improving Outcomes in Intermittent Exotropia (IOXT) Study group. Surgical intervention in childhood intermittent exotropia: current practice and clinical outcomes from an observational cohort study. Br J Ophthalmol. 2012 Oct;96(10):1291-5. doi: 10.1136/bjophthalmol-2012-301981. Epub 2012 Aug 11.
- Results publication: PubMed 6657192Richard JM, Parks MM. Intermittent exotropia. Surgical results in different age groups. Ophthalmology. 1983 Oct;90(10):1172-7.
- Results publication: PubMed 930997Pratt-Johnson JA, Barlow JM, Tillson G. Early surgery in intermittent exotropia. Am J Ophthalmol. 1977 Nov;84(5):689-94. doi: 10.1016/0002-9394(77)90385-3. No abstract available.
- Results publication: PubMed 14736781Haggerty H, Richardson S, Hrisos S, Strong NP, Clarke MP. The Newcastle Control Score: a new method of grading the severity of intermittent distance exotropia. Br J Ophthalmol. 2004 Feb;88(2):233-5. doi: 10.1136/bjo.2003.027615.
- Results publication: PubMed 11162985Abroms AD, Mohney BG, Rush DP, Parks MM, Tong PY. Timely surgery in intermittent and constant exotropia for superior sensory outcome. Am J Ophthalmol. 2001 Jan;131(1):111-6. doi: 10.1016/s0002-9394(00)00623-1.
- Results publication: PubMed 21665502Choi J, Kim SJ, Yu YS. Initial postoperative deviation as a predictor of long-term outcome after surgery for intermittent exotropia. J AAPOS. 2011 Jun;15(3):224-9. doi: 10.1016/j.jaapos.2010.12.019. Epub 2011 Jun 12.
- Changing patterns of strabismus: a decade of experience in Hong KongLink provided by the sponsor.
- Binocular Vision and Ocular Motility THEORY AND MANAGEMENT OF STRABISMUSLink provided by the sponsor.
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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.
Ayman Elshiaty, MD study director
Head of Ophthalmology Department, Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Exotropia, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Ahmed R Awadein, MD (00201223911743, ahmedawadein@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor success rate (time frame: Six 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 NCT04307160, which also lists 6 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 13 Mar 2020.