Efficacy of Blue Wavelength in Managing Dry Eye
Primary Purpose
Dry Eye Disease
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Digital blue light blocking filter
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
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
Sites / Locations
- The university of Faisalabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1 blue light blocking filter group
2 non filter users
Arm Description
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.
Effect of time duration of digital screen on the dry eyes is checked.
Outcomes
Primary Outcome Measures
tear break up time
improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.
Schirmer test values
improvement in aqueous deficient dry eye by Schirmer test values in mm .
corneal surface staining
'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use
Secondary Outcome Measures
ocular surface disease index questionnaire
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 .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04965974
Brief Title
Efficacy of Blue Wavelength in Managing Dry Eye
Official Title
Efficacy of Blue Wavelength in Managing Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Faisalabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 blue light blocking filter group
Arm Type
Experimental
Arm Description
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.
Arm Title
2 non filter users
Arm Type
Experimental
Arm Description
Effect of time duration of digital screen on the dry eyes is checked.
Intervention Type
Device
Intervention Name(s)
Digital blue light blocking filter
Other Intervention Name(s)
F.lux and blue light filter Night mode,Night shift
Intervention Description
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
Primary Outcome Measure Information:
Title
tear break up time
Description
improvement in evaporative dry eye will be assessed by improvement in tear break up time in seconds after filter use.
Time Frame
8 weeks
Title
Schirmer test values
Description
improvement in aqueous deficient dry eye by Schirmer test values in mm .
Time Frame
8 weeks
Title
corneal surface staining
Description
'corneal surface staining grade scale' assess the improvement corneal surface erosions after filter use
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
ocular surface disease index questionnaire
Description
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 .
Time Frame
8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The tendency of dry eye disease is more in females .
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Komal Atta, mbbs
Phone
03224075007
Email
komal.atta@tuf.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Nimra Gul, m.phil od
Phone
03156673622
Email
Nimra.gul@tuf.edu.pk
Facility Information:
Facility Name
The university of Faisalabad
City
Faisalābad
State/Province
Punjab Pakistan
ZIP/Postal Code
38000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimra Gul, M.phil
Phone
0315 66773622
Email
Nimra.gul@tuf.edu.pk
First Name & Middle Initial & Last Name & Degree
Komal Atta, mbbs
Phone
03224075007
Email
komal.atta@tuf.edu.pk
First Name & Middle Initial & Last Name & Degree
Shumaila Masood, M.phil
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Blue Wavelength in Managing Dry Eye
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