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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05964673
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
3
Anticipated Duration (Months)
20.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: bioptron light therapy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women
Actual Study Start Date :
May 9, 2023
Anticipated Primary Completion Date :
Jul 19, 2023
Anticipated Study Completion Date :
Aug 8, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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. extremely good very good good bad very bad extremely bad

  2. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University Cairo, Egypt 11432

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Sara Ahmed, lecturer, giza, Egypt, 12511

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alaa Mohamed El-Moatasem Mohamed, lecturer of physical therapy, Cairo University
ClinicalTrials.gov Identifier:
NCT05964673
Other Study ID Numbers:
  • P.T.REC/012/004549
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
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

Study Results

No Results Posted as of Jul 28, 2023