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

Not Applicable

Recruiting

• Conditions: Postmenopausal Women
• Interventions: Device: bioptron light therapy

• Registration Number: NCT05964673
• Lead Sponsor: Cairo University

Brief 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

Detailed 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

Study Timeline

• Study Start: 2023-05-09
• Study First Submitted: 2023-07-18
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-07-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2023-09-19
• Study Completion: 2023-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• All participants are postmenopausal women.
• Their age above 50 years old
• All participants aren't on any systematic therapy.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bioptron light therapy group	bioptron light therapy	Patients will be sitting in a comfortable chair, with their eyes closed, with cleaned eyelids, and occasionally blinking. Bioptron lamp will be lined at an angle of 90°, at a distance from 5 cm to 10 cm, exposure time will be 5 min. Energy is very low, 1 - 2.4 J/cm without thermal effects, energy density is 40mW. Bioptron light is polychrome, wave frequency is from 400 nm (including blue, visible radiation) up to 2000 nm (representing infrared waves)

Primary Outcome Measures

Name	Time	Method
Dry Eye-Related Quality-Of-Life Score (DEQS)	Dry Eye-Related Quality-Of-Life Score will be measured at baseline, and it will be measured again after four weeks	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.; 1. extremely good; 2. very good; 3. good; 4. bad; 5. very bad; 6. extremely bad
Tear Breakup Time (TBUT)	Tear Breakup Time will be measured at baseline, and it will be measured again after four weeks	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.

Secondary Outcome Measures

Name	Time	Method
Schirmer's test	Schirmer's test will be measured at baseline, and after four weeks	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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo,, Egypt