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

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

Study Overview

• Status: Recruiting
• Conditions: Postmenopausal Women
• Intervention / Treatment: Device: bioptron light therapy

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Ahmed, lecturer; Phone Number: 01063998331; Email: Saramagdy87@cu.edu.eg
• Study Contact Backup: Name: Amel Yousef, Professor; Phone Number: 01222726511; Email: Amelyousef@pt.cu.edu.eg

Study Locations

• Egypt
  • Cairo,, Egypt, 11432
    • Recruiting
    • Cairo University
    • Contact: Amel Yousef, Professor; Phone Number: 01222726511; Email: Amelyousef@pt.cu.edu.eg
    • Contact: Rania Ahmed, Assistant professor; Phone Number: 01001593155; Email: roni_diamond@yahoo.com
    • Principal Investigator: Ehab Saad, Assistant lecturer
    • Principal Investigator: Sara Ahmed, Lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: education program group; this group will receive patient education program for four weeks.; limiting screen time; blinking awareness training; keeping the home environment cool and moist; using artificial tears (Hylo®gel) twice daily; contact lens use can preferably be limited,; adding omega-3 poly unsaturated fatty acids in the diet or as dietary supplements.
Experimental: bioptron light therapy group; 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)	Device: bioptron light therapy; patients will receive patient education program and bioptron light therapy for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Sara Ahmed, lecturer, giza, Egypt, 12511

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2023
• Primary Completion (Estimated): September 19, 2023
• Study Completion (Estimated): November 8, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: P.T.REC/012/004549

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes