Computer Vision Syndrome Visual Sequelae

Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial

the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations

Study Overview

• Status: Completed
• Conditions: Computer Vision Syndrome
• Intervention / Treatment: Diagnostic test: mfERG (multifocal-retinogram)

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 Type: Interventional
• Enrollment (Actual): 733
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82425
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- University students

Exclusion Criteria:

• Amblyopia
• Anisometropia
• strabismus
• Previous eye surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month
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	1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 21, 2018
• Primary Completion (ACTUAL): June 15, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 5-10/4/2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No