Efficacy of Blue Wavelength in Managing Dry Eye

July 16, 2021 updated by: Shumaila Masood, University of Faisalabad

The study is conducted to evaluate the efficacy of digital blue light blocking filter in improvement of clinical indices of dry eye and ocular symptoms related to dry eye.

Introduction: Dry eye disease is a multifactorial disease of the ocular surface caused by loss of tear film homeostasis resulting damage to the ocular surface and neurosensory abnormalities.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

60 subjects aged 20-35 years with ocular surface disease index score greater than 13 will be taken from the University of Faisalabad. After taking consent, procedure starts from history then Schirmer test 1 will be performed to measure the tear deficient dry eye. Tear break up time will be done to assess the evaporative dry eye. Corneal surface staining will be used to measure corneal erosions. OSDI questionnaire will be used for the evaluation of ocular symptoms related to dry eye. The digital blue light blocking filter will be randomly installed in digital devices of the 80 subjects and rest of 80 will be without filter. After baseline data follow ups will be after 3 weeks and second after 8 weeks of filter use. Schirmer test 1, tear break up time corneal surface staining and OSDI will be performed on both groups (filter users and non-filter users) for the evaluation of dry eye. Data will be analyzed using SPSS version 21. Result of this study will give knowledge that use of digital blue light blocking filters are useful in the management of dry eye disease.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Pakistan
      • Faisalābad, Punjab Pakistan, Pakistan, 38000
        • The University of Faisalabad
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shumaila Masood, M.phil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females with age 20-35years
  • using digital devices androids and laptops
  • Ametropia of up to 1.0 Diopter sphere(DS) and astigmatism of less than 0.5
  • Emmetropes.

Exclusion Criteria:

  • Subjects using topical drugs
  • Smokers
  • Subjects undergoing dry eye treatment
  • History of contact lens wear within the past three months
  • Corneal surface disease other than dry eye
  • Corneal or eyelid infections
  • Corneal surgeries
  • Refractive error of more than 1 DS of SE and astigmatism of greater than0.5DC
  • Age <18 and >3 years
  • Subjects already using blue light blocking filters
  • I phone users
  • Pregnant women
  • Males

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 blue light blocking filter group
digital blue light blocking filter is installed laptops and mobile phones of 80 individual using digital devices more than 4 hours. asked them to use the filter continuously while using digital devices.
Device: Digital blue light blocking filter
digital blue light blocking filter will be given to 80 dry eye subjects in mobile phones and laptops and 80 individuals will be without filters digital devices users
Other Names:
  • F.lux and blue light filter Night mode,Night shift
Experimental: 2 non filter users
Effect of time duration of digital screen on the dry eyes is checked.
Device: Digital blue light blocking filter
digital blue light blocking filter will be given to 80 dry eye subjects in mobile phones and laptops and 80 individuals will be without filters digital devices users
Other Names:
  • F.lux and blue light filter Night mode,Night shift

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tear break up time
Time Frame: 8 weeks
improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.
8 weeks
Schirmer test values
Time Frame: 8 weeks
improvement in aqueous deficient dry eye by Schirmer test values in mm .
8 weeks
corneal surface staining
Time Frame: 8 weeks
'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ocular surface disease index questionnaire
Time Frame: 8 weeks
improvement in ocular surface disease index score.13-22ocular surface disease index score mild dry eye ,23-32 score means moderate dry eye and ocular surface disease index greater than 33 indicate severe dry eye .
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUF/MPO/2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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