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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05964673
Enrollment
60
Registered
2023-07-28
Start date
2023-05-09
Completion date
2023-11-08
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Women

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

Interventions

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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 weeksThe 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 weeksTear 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

MeasureTime frameDescription
Schirmer's testSchirmer's test will be measured at baseline, and after four weeksThe 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.

Countries

Egypt

Contacts

Primary ContactSara Ahmed, lecturer
Saramagdy87@cu.edu.eg01063998331
Backup ContactAmel Yousef, Professor
Amelyousef@pt.cu.edu.eg01222726511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026