Alternating ExotropiaNCT04308538
Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6
A study testing Standard Recession and Reduced Recession in people with Alternating Exotropia, run by Cairo University at 1 site in Egypt.
Trial summary
comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Alternating Exotropia
- What is being tested?
- Standard Recession and Reduced Recession
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
- Basic, pseudo- divergence excess and divergence excess types are included.
- If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).
Who cannot join
- Intermittent exotropia of the convergence insufficiency type.
- Intermittent exotropia with angle of deviation greater than 50 prism diopters.
- Patients with previous squint surgery.
- Patients with secondary deviation due to a sensory lesion or neurological condition.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Cairo university
Cairo
Ahmed Siam, Masters, 1111447245 ext. +20, dr_sheded@hotmail.com
Ahmed Awadein, doctorate
About this study
Official title: Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old
comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter
- Conditions
- Alternating Exotropia
- Being tested
- Standard Recession, Reduced Recession
- Medical subject headings
- Exotropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard RecessionProcedure or surgery
Bilateral lateral rectus muscle recession will be performed through fornix approach using standard tables
Reduced RecessionProcedure or surgery
Bilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers
| Study group | Role | What they receive |
|---|---|---|
| Standard Recession | Active comparator | Bilateral lateral rectus muscle recession using standard tables stated by Parks. Receives: Procedure: Standard Recession |
| Reduced Recession | Experimental | Bilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables. Receives: Procedure: Reduced Recession |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor success rate
Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)
Measured: 6 months
Secondary outcomes (1)
Pattern strabismus
Number of patients who develop pattern strabismus
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2022 (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 Alternating 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
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 chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308538
- Sponsor's protocol ID
- D-20-2020
- Status last verified
- Mar 2020
- First submitted
- 18 Apr 2015
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haggerty 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 14736781Pratt-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 930997Abroms 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 11162985Buck 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 22887975
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old
- ClinicalTrials.gov ID
- NCT04308538
- Acronym / sponsor ID
- D-20-2020
- Conditions
- Alternating Exotropia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 16 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.
comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Recession | Active comparator | Procedure: Standard RecessionBilateral lateral rectus muscle recession using standard tables stated by Parks. |
| Reduced Recession | Experimental | Procedure: Reduced RecessionBilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
- Basic, pseudo- divergence excess and divergence excess types are included.
- If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).
Key exclusion criteria (4 listed)
- Intermittent exotropia of the convergence insufficiency type.
- Intermittent exotropia with angle of deviation greater than 50 prism diopters.
- Patients with previous squint surgery.
- Patients with secondary deviation due to a sensory lesion or neurological condition.
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 |
|---|---|---|
| Standard RecessionBilateral lateral rectus muscle recession will be performed through fornix approach using standard tables | Procedure or surgery | Standard Recession |
| Reduced RecessionBilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers | Procedure or surgery | Reduced Recession |
Primary outcome
Motor success rate
Time frame: 6 months
Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)
1 secondary outcome
Pattern strabismus
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: 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 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 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 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.
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 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 Standard Recession and Reduced Recession in people with Alternating 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 3 inclusion and 4 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 16 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Awadein, MD (+201223911743, 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: 6 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 NCT04308538, 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 16 Mar 2020.