NCT05964673

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

July 18, 2023

Last Update Submit

August 28, 2023

Conditions

Postmenopausal Women

Outcome Measures

Primary Outcomes (2)

  • 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. 1. extremely good 2. very good 3. good 4. bad 5. very bad 6. 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 Outcomes (1)

  • Schirmer's test

    Schirmer's test will be measured at baseline, and after four weeks

Study Arms (2)

education program group

NO INTERVENTION

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

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

Interventions

bioptron light therapyDEVICE

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

bioptron light therapy group

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants are postmenopausal women.
  • Their age above 50 years old
  • All participants aren't on any systematic therapy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 11432, Egypt

RECRUITING

Related Publications (1)

  • Mohamed Elsayed Saad E, Magdy Ahmed S, Mohamed Yousef A, Shahat Hassan E. Effect of Bioptron light therapy on dryness of eyes in postmenopausal women: a randomized controlled trial. Lasers Med Sci. 2026 Feb 4;41(1):20. doi: 10.1007/s10103-026-04807-6.

    PMID: 41634440DERIVED

Study Officials

  • Sara Ahmed, lecturer

    giza, Egypt, 12511

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Ahmed, lecturer

CONTACT

01063998331Saramagdy87@cu.edu.eg

Amel Yousef, Professor

CONTACT

01222726511Amelyousef@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 28, 2023

Study Start

May 9, 2023

Primary Completion

September 19, 2023

Study Completion

November 8, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

EG(1)