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

Cairo University (CU)

Status: Enrolling

Conditions: Postmenopausal Women

Treatments: Device: bioptron light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05964673

P.T.REC/012/004549

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

education program group

No Intervention group

Description:

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.

bioptron light therapy group

Experimental group

Description:

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)

Treatment:

Device: bioptron light therapy