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Choroidal and Retinal Thickness Following Strabismus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285177
Recruitment Status : Enrolling by invitation
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Heba Shafik, Tanta University

Tracking Information
First Submitted Date February 23, 2020
First Posted Date February 26, 2020
Last Update Posted Date February 26, 2020
Actual Study Start Date February 15, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 23, 2020)
Choroidal and retinal thickness change after strabismus surgery [ Time Frame: preoperative, 1st week, 1st month, and 3 months ]
Measured by Spectral Domain Optical coherence tomography
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Choroidal and Retinal Thickness Following Strabismus Surgery
Official Title Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography
Brief Summary Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery
Detailed Description

This is a prospective study and will be conducted in Tanta University hospital

  • Duration: February 2020 till May 2020 and may be extended
  • The study will include 30 patients who suffer from esotropia or exotropia, inferior oblique (IO) over-action with or without any other type of horizontal deviation

Pre-operative measurement of the macular and choroidal thickness by Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT).

Post-operative measurement: First day, first week, one month then 3 months.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All individual with strabismus fulfilling the inclusion criteria
Condition
  • Strabismus
  • Retinal Thickening
Intervention Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy
Study Groups/Cohorts
  • Horizontal muscle surgery
    Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection
    Intervention: Procedure: Strabismus surgery
  • Patients with Inferior Oblique Overaction
    Will undergo inferior Oblique Myectomy
    Intervention: Procedure: Strabismus surgery
  • Patients with combined horizontal and oblique muscle surgery
    Having combined surgery
    Intervention: Procedure: Strabismus surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: February 23, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • No prior history of ocular surgery or trauma
  • Normal ocular examination findings
  • No medical or family history of retinal disease, glaucoma or diabetes mellitus.

Exclusion Criteria:

  • Patients with orbital and/or craniofacial abnormalities
  • Patients with sensory or restrictive strabismus or neurological disease
  • Preoperative retinal or macular pathology
  • Patient who is unable to cooperate to do OCT scanning
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04285177
Other Study ID Numbers TUORU003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Heba Shafik, Tanta University
Study Sponsor Tanta University
Collaborators Not Provided
Investigators
Principal Investigator: Sharif Y El Emam, MD Tanta University
PRS Account Tanta University
Verification Date February 2020