Laser Acupuncture for Dry Eye Disease Due to Visual Display Terminal Use

NCT06688630 | Completed

• 1 other identifier: 24-09-1470
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to determine whether laser acupuncture can alleviate dry eye symptoms caused by visual display terminal use and to assess the safety of laser acupuncture. The research questions to be addressed are:

• Can laser acupuncture and artificial tears reduce the Ocular Surface Disease Index (OSDI) score, Tear Break-Up Time (TBUT) score, Ocular Surface Staining (OSS) score, and Schirmer Test score?
• Are there any side effects associated with laser acupuncture therapy? The researchers will compare laser acupuncture and artificial tears with sham laser acupuncture (a procedure using the same device but without activating the laser, so no energy is emitted) to assess whether laser acupuncture and artificial tears can effectively treat dry eye associated with visual display terminal use. Participants will:
• Receive either laser acupuncture therapy or sham laser acupuncture therapy for 6 sessions, twice a week, over a 3-week period.
• Use artificial tears daily, 4 times per day (morning, afternoon, evening, and night), with one drop per eye for both eyes, over a 4-week period.
• Attend follow-up visits at the eye clinic at baseline (before therapy), in week 2, and in week 4.
• Record any side effects observed after each session of laser acupuncture therapy.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• The Ocular Surface Disease Index

  The Ocular Surface Disease Index (OSDI) is a questionnaire consisting of 12 questions designed to assess symptoms of dry eye, visual function, and environmental factors that may trigger dry eye.

  Before therapy, week 2, week 4

• The Tear Break-up Time

  Tear Break-Up Time (TBUT) is an examination used to assess how long the tear film remains on the ocular surface after blinking, as a measure for diagnosing dry eye. This test is conducted by an ophthalmologist.

  Before therapy, week 2, week 4

Secondary Outcomes (4)

• The Ocular Surface Staining Score

  Before therapy, week 2, week 4

• The Schirmer Score

  Before therapy, week 2, week 4

• The Visual Analog Scale

  Before therapy, week 2, week 4

• Adverse Event

  Up to week 4

Study Arms (2)

Intervention Group

EXPERIMENTAL

The laser acupuncture and artificial tears therapy

Device: The laser acupuncture and artificial tears therapy

Control Group

SHAM COMPARATOR

The sham laser acupuncture and artificial tears therapy

Device: The sham laser acupuncture and artificial tears therapy

Interventions

The laser acupuncture and artificial tears therapy DEVICE

Laser acupuncture therapy is the application of a Reimers \& Janssen LaserPen, with a power of 150mW and a wavelength of 810nm, alternating between Nogier frequencies A and C. The dosage is 2 joules per point, with a therapy duration of 26 seconds per point, targeting bilateral acupuncture points BL2, TE23, ST2, LI4, and ST36. The LaserPen is applied without pressing the laser probe onto the body surface. Artificial tears containing carboxymethylcellulose (CMC) will be used. The frequency of application is four times daily (morning, afternoon, evening, and night), with one drop per eye, administered to both eyes. Artificial tears will be used throughout the study duration (4 weeks). Use of any artificial tears other than CMC will be discontinued for 3 days and resumed on day 4 with CMC.

Intervention Group

The sham laser acupuncture and artificial tears therapy DEVICE

Laser acupuncture therapy is a procedure using the same device but without activating the laser, so no energy is emitted. Performed at the same points as laser acupuncture therapy. Artificial tears containing carboxymethylcellulose (CMC) will be used. The frequency of application is four times daily (morning, afternoon, evening, and night), with one drop per eye, administered to both eyes. Artificial tears will be used throughout the study duration (4 weeks). Use of any artificial tears other than CMC will be discontinued for 3 days and resumed on day 4 with CMC.

Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women aged 18 - 59 years with dry eye complaints
• Diagnosed with DED by an Ophthalmologist with the criteria OSDI value ≥ 13, and TBUT value \< 10 seconds
• Using VDT for at least 4 hours a day
• Not currently receiving other DED therapy other than CMC artificial tears
• Willing to participate in the study until completion and sign the informed consent

You may not qualify if:

• Acute infection or trauma to the eye and periorbita
• Eyelid abnormalities or facial paresis that prevent the eye from closing
• History of intraocular or extraocular surgery within the last 12 months
• Previously diagnosed with Steven Johnson Syndrome, Sjogren Syndrome, or diabetes mellitus
• Undergoing chemotherapy or post-chemotherapy
• Pregnant and lactating women
• Menopausal women or those receiving hormone therapy
• History of uncontrolled seizures or epilepsy

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, the ophthalmologist conducting the eye examinations, and the outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Medical Acupuncture Study Program

Model Details: This study will compare the combination of laser acupuncture therapy and artificial tears with the combination of sham laser acupuncture therapy and artificial tears. The laser acupuncture and artificial tears therapy will be designated as the intervention group, while the sham laser acupuncture and artificial tears therapy will be designated as the control group.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: December 27, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)