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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-09

Study Completion Date

2023-11-08

Brief Summary

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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

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Detailed Description

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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

Conditions

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Postmenopausal Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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education program group

this group will receive patient education program for four weeks.

1. limiting screen time
2. blinking awareness training
3. keeping the home environment cool and moist
4. using artificial tears (Hylo®gel) twice daily
5. contact lens use can preferably be limited,
6. adding omega-3 poly unsaturated fatty acids in the diet or as dietary supplements.

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

bioptron light therapy

Intervention Type DEVICE

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

Interventions

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bioptron light therapy

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No