Clinical trial NCT04965974: Efficacy of Blue Wavelength in Managing Dry Eye
Official title: Efficacy of Blue Wavelength in Managing Dry Eye
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2021-07-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: tear break up time
timeFrame: 8 weeks
measure: Schirmer test values
timeFrame: 8 weeks
measure: corneal surface staining
timeFrame: 8 weeks
Secondary outcomes:
measure: ocular surface disease index questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: The university of Faisalabad
state: Punjab Pakistan
Study officials:
References: