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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

Brief Summary:
Prospective study, conducted at Tanta University Ophthalmology Department Measurement of macular and choroidal thickness before and after strabismus surgery

Condition or disease Intervention/treatment
Strabismus Retinal Thickening Procedure: 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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Strabismus Surgery on Macular and Subfoveal Choroidal Thickness Assessed by Spectral Domain Optical Coherence Tomography
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Horizontal muscle surgery
Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection
Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy

Patients with Inferior Oblique Overaction
Will undergo inferior Oblique Myectomy
Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy

Patients with combined horizontal and oblique muscle surgery
Having combined surgery
Procedure: Strabismus surgery
Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All individual with strabismus fulfilling the inclusion criteria
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

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): NCT04285177


Locations
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Egypt
Tanta University Hospital
Tanta, Gharbeya, Egypt, 31111
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Sharif Y El Emam, MD Tanta University
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Responsible Party: Heba Shafik, Clinical Associate Professor, Tanta University
ClinicalTrials.gov Identifier: NCT04285177    
Other Study ID Numbers: TUORU003
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases