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

NCT06688630 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-03-19

No results posted yet for this study

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

Interventions

DEVICE

The laser acupuncture and artificial tears therapy

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.

DEVICE

The sham laser acupuncture and artificial tears therapy

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • KPEK FKUI-RSCM · The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2025-03-14
Completion
2025-03-14

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688630 on ClinicalTrials.gov