Efficacy of Blue Wavelength in Managing Dry Eye

Sponsor
University of Faisalabad (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04965974
Collaborator
(none)
160
1
2
1
157.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Digital blue light blocking filter
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Blue Wavelength in Managing Dry Eye
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Aug 1, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. tear break up time [8 weeks]

      improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.

    2. Schirmer test values [8 weeks]

      improvement in aqueous deficient dry eye by Schirmer test values in mm .

    3. corneal surface staining [8 weeks]

      'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use

    Secondary Outcome Measures

    1. ocular surface disease index questionnaire [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 .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The university of Faisalabad Faisalābad Punjab Pakistan Pakistan 38000

    Sponsors and Collaborators

    • University of Faisalabad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shumaila Masood, Principal investigator, University of Faisalabad
    ClinicalTrials.gov Identifier:
    NCT04965974
    Other Study ID Numbers:
    • TUF/MPO/2101
    First Posted:
    Jul 16, 2021
    Last Update Posted:
    Jul 23, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 23, 2021