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Computer Vision Syndrome Visual Sequelae

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04398212
Collaborator
(none)
733
Enrollment
1
Location
2
Arms
26.4
Actual Duration (Months)
27.8
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: mfERG (multifocal-retinogram)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
733 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Diagnostic
Official Title:
Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial
Actual Study Start Date :
May 21, 2018
Actual Primary Completion Date :
Jun 15, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Non-complaining group

the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it

Diagnostic Test: mfERG (multifocal-retinogram)
mfERG will be performed for the students to document the effect of CVS on retina
Experimental: Complaining group

the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings

Diagnostic Test: mfERG (multifocal-retinogram)
mfERG will be performed for the students to document the effect of CVS on retina

Outcome Measures

Primary Outcome Measures

  1. visual acuity [1 month]

    visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time

  2. near vision [1 month]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • University students
Exclusion Criteria:

  • Amblyopia

  • Anisometropia

  • strabismus

  • Previous eye surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine Sohag Egypt 82425

Sponsors and Collaborators

  • Sohag University

Investigators

  • Principal Investigator: Mohammed Iqbal, MD. PhP, Sohag University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Mohammed Iqbal, Assistant Professor of Ophthalmology, Sohag University
ClinicalTrials.gov Identifier:
NCT04398212
Other Study ID Numbers:
  • 5-10/4/2018
First Posted:
May 21, 2020
Last Update Posted:
Aug 10, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Syndrome

Study Results

No Results Posted as of Aug 10, 2020