Efficacy of Blue Wavelength in Managing Dry Eye

Dry Eye Disease Clinical Trial

Official title:

Efficacy of Blue Wavelength in Managing Dry Eye

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04965974
• Other study ID #: TUF/MPO/2101
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: University of Faisalabad
• Contact: Komal Atta, mbbs
• Phone: 03224075007
• Email: komal.atta[@]tuf.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: August 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
Pakistan	The university of Faisalabad	Faisalabad	Punjab Pakistan

Sponsors (1)

Lead Sponsor	Collaborator
University of Faisalabad

Country where clinical trial is conducted

Pakistan, 

Outcome

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