NCT04303832

Brief Summary

It will be hypothesized that:

  • Eye exercises have a positive effect on correction of remaining ocular deviation post strabismus surgery.
  • Eye exercises have a positive effect on improving amplyobia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

March 4, 2020

Last Update Submit

March 7, 2020

Conditions

Keywords

Strabismus and amplyobia and physiotherapy eye exercise

Outcome Measures

Primary Outcomes (1)

  • change in angle of deviation

    deviation of the eye in direction rather than its normal position

    pre and post 12 weeks

Secondary Outcomes (1)

  • change in visual acuity

    pre and post 12 weeks

Study Arms (2)

eye exercise group

EXPERIMENTAL

This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses

Other: eye exercisesDevice: eye glasses

control group

SHAM COMPARATOR

This group had traditional treatment of strabismus which is eye glasses

Device: eye glasses

Interventions

Eye exercises for correcting eye deviation

eye exercise group

Eye glasses for correcting eye deviation

control groupeye exercise group

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients received strabismus operation
  • All types of strabismus surgery will be included
  • They selected from Outpatient Clinic
  • Patients begin the training program after 2 weeks of operation or more than this
  • The patient still suffering from amblyopia post strabismus surgery

You may not qualify if:

  • Muscular disorders that will impair performance during training.
  • Neurological disorders.
  • Malignant conditions.
  • Psychiatric illness, severe behavior or cognitive disorders. Children who can't understand the therapist's instructions and orders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

StrabismusAmblyopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesBrain DiseasesCentral Nervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • Amany Abdel Wahid, M.Sc

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 11, 2020

Study Start

October 1, 2018

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

information about statistical analysis and study report will be sheared with other researcher later on

Shared Documents
SAP, CSR
Time Frame
later on
Access Criteria
for physical therapist and ophthalmologist

Locations