NCT04285177

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 23, 2020

Last Update Submit

February 23, 2020

Conditions

StrabismusRetinal Thickening

Outcome Measures

Primary Outcomes (1)

  • Choroidal and retinal thickness change after strabismus surgery

    Measured by Spectral Domain Optical coherence tomography

    preoperative, 1st week, 1st month, and 3 months

Study Arms (3)

Horizontal muscle surgery

Patients suffering from esotropia or exotropia, will have medial/lateral rectus recession/resection

Procedure: Strabismus surgery

Patients with Inferior Oblique Overaction

Will undergo inferior Oblique Myectomy

Procedure: Strabismus surgery

Patients with combined horizontal and oblique muscle surgery

Having combined surgery

Procedure: Strabismus surgery

Interventions

Strabismus surgeryPROCEDURE

Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy

Horizontal muscle surgeryPatients with Inferior Oblique OveractionPatients with combined horizontal and oblique muscle surgery

Eligibility Criteria

Age7 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All individual with strabismus fulfilling the inclusion criteria

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 31111, Egypt

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Sharif Y El Emam, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 26, 2020

Study Start

February 15, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 26, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)