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Relationship of Age at Surgery to Surgical Outcome After Surgery for Intermittent Exotropia

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ClinicalTrials.gov Identifier: NCT04307160
Recruitment Status : Not yet recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Awadein, Cairo University

Brief 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.

Condition or disease Intervention/treatment
Intermittent Exotropia Procedure: Bilateral lateral rectus recession

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Effect of Age at Time of Surgery on the Surgical Outcome After Bilateral Lateral Rectus Muscle Recession in Intermittent Exotropia
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Group/Cohort Intervention/treatment
Group I
Patients ≤ 5 years of age
Procedure: Bilateral lateral rectus recession
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

Group II
Patients ≥ 7 years of age
Procedure: Bilateral lateral rectus recession
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




Primary Outcome Measures :
  1. Motor success rate [ Time Frame: Six months ]
    Success rate defined as deviation between exotropia/phoria of 8 PD to esotropia/phoria of 4 PD


Secondary Outcome Measures :
  1. Change in stereoacuity [ Time Frame: Six months ]
    Average log improvement of stereoacuity using TNO test at 6 months

  2. New misalignment [ Time Frame: Six months ]
    Number of patients who developed underaction, or overaction of horizontal or oblique muscles

  3. Pattern deviation [ Time Frame: Six months ]
    Number of patient who develop new A or V pattern after surgery.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307160


Contacts
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Contact: Ahmed R Awadein, MD 00201223911743 ahmedawadein@yahoo.com
Contact: Jylan A Gouda, MSc 00201285430887 gilangouda@yahoo.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ayman Elshiaty, MD Head of Ophthalmology Department, Cairo University
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Ahmed Awadein, Professor of Ophthalmology, Cairo University
ClinicalTrials.gov Identifier: NCT04307160    
Other Study ID Numbers: D-31-2019
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases