Back to resultsComputer Vision Syndrome Visual Sequelae
Primary Purpose
Computer Vision Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mfERG (multifocal-retinogram)
Sponsored by
About this trial
This is an interventional diagnostic trial for Computer Vision Syndrome
Eligibility Criteria
Inclusion Criteria:
- University students
Exclusion Criteria:
- Amblyopia
- Anisometropia
- strabismus
- Previous eye surgery
Sites / Locations
- Faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Non-complaining group
Complaining group
Arm Description
the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it
the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings
Outcomes
Primary Outcome Measures
visual acuity
visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time
near vision
near vision changes following reduction of screen hours using card test, near visual acuity chart and near point test while the measurements will be diopters and lines of near chart
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04398212
Brief Title
Computer Vision Syndrome Visual Sequelae
Official Title
Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
June 15, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations
Detailed Description
CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Computer Vision Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
733 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-complaining group
Arm Type
Placebo Comparator
Arm Description
the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it
Arm Title
Complaining group
Arm Type
Experimental
Arm Description
the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings
Intervention Type
Diagnostic Test
Intervention Name(s)
mfERG (multifocal-retinogram)
Intervention Description
mfERG will be performed for the students to document the effect of CVS on retina
Primary Outcome Measure Information:
Title
visual acuity
Description
visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time
Time Frame
1 month
Title
near vision
Description
near vision changes following reduction of screen hours using card test, near visual acuity chart and near point test while the measurements will be diopters and lines of near chart
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- University students
Exclusion Criteria:
Amblyopia
Anisometropia
strabismus
Previous eye surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Iqbal, MD. PhP
Organizational Affiliation
Sohag University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine
City
Sohag
ZIP/Postal Code
82425
Country
Egypt
12. IPD Sharing Statement
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Computer Vision Syndrome Visual Sequelae
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