NCT04398212

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
733

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

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

May 21, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

May 18, 2020

Last Update Submit

August 7, 2020

Conditions

Computer Vision Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Non-complaining group

PLACEBO COMPARATOR

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)

Complaining group

EXPERIMENTAL

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)

Interventions

mfERG (multifocal-retinogram)DIAGNOSTIC_TEST

mfERG will be performed for the students to document the effect of CVS on retina

Complaining groupNon-complaining group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- University students

You may not qualify if:

  • Amblyopia
  • Anisometropia
  • strabismus
  • Previous eye surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Sohag, 82425, Egypt

Location

Study Officials

  • Mohammed Iqbal, MD. PhP

    Sohag University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 21, 2020

Study Start

May 21, 2018

Primary Completion

June 15, 2020

Study Completion

August 1, 2020

Last Updated

August 10, 2020

Record last verified: 2020-08

Locations

EG(1)