Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women

Postmenopausal Women Clinical Trial

Official title:

Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964673
• Other study ID #: P.T.REC/012/004549
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: November 8, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Sara Ahmed, lecturer
• Phone: 01063998331
• Email: Saramagdy87[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Dry eye disease (DED) is a growing public health concern affecting quality of life and visual function, with a significant socio-economic impact. It is more prevalent in the females and is being specifically in the menopausal and postmenopausal age group.

Bioptron light therapy is efficient in the elimination of allergic reactions, signs and symptoms of dry eye improving capillary circulation, immunity stimulation, relieving pain and establishing balance of tissue electromagnetic field

Description:

Around 60 postmenopausal women will be randomly divided into two equal groups, they all complain from dry eye symptoms, ranging from mild/normal to moderate and severe.

Group(A): will receive patient education program for four weeks. Group(B): will receive patient education program and bioptron light therapy for four weeks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 8, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• All participants are postmenopausal women.

• Their age above 50 years old

• All participants aren't on any systematic therapy.

Exclusion Criteria:

• • Injuries and previous surgical treatment of eyes

• All patients with diagnosis of chronic blepharitis, meibominitis or any other eye infections

• Participants with autoimmune diseases such as Sjögren's syndrome (SS), rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE)

• Diabetic participants will be excluded.

• Smokers will be excluded from the study.

• The use of Hormone Replacement Therapy

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Device:
• bioptron light therapy
patients will receive patient education program and bioptron light therapy for four weeks

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo,

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dry Eye-Related Quality-Of-Life Score (DEQS)	The Dry Eye-Related Quality-Of-Life Score questionnaire is a 15-item instrument for assessing subjective dry eye symptoms and their effects on activities of daily living within the previous week.; extremely good; very good; good; bad; very bad; extremely bad	Dry Eye-Related Quality-Of-Life Score will be measured at baseline, and it will be measured again after four weeks
Primary	Tear Breakup Time (TBUT)	Tear Breakup Time Is the time interval between a complete blink and the appearance of the first break, discontinuity or dry spot observed in the tear film.	Tear Breakup Time will be measured at baseline, and it will be measured again after four weeks
Secondary	Schirmer's test	The Schirmer test score is determined by the length of the moistened area of the strips (using the scale packaged with the strips) and the duration of the measurement in minutes. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency.	Schirmer's test will be measured at baseline, and after four weeks