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

NCT ID: NCT06688630

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-27
• Study Completion Date: 2025-03-14

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.

Detailed Description

• Dry eye disease is an ocular condition characterized by common symptoms such as eye irritation, a sensation of grittiness, foreign body sensation, stickiness, itchiness, eye fatigue, redness, stabbing or burning sensations, increased blinking frequency, and symptom exacerbation in the afternoon or evening.
• Visual Display Terminal (VDT) refers to devices equipped with a screen for displaying graphics or digital content for specific tasks, commonly known as gadgets. Examples of VDTs include computers, laptops, televisions, and mobile phones.
• 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.
• The Visual Analog Scale (VAS) is a scoring tool to measure the intensity of discomfort associated with dry eye, using a scale from 0 to 100, where 0 indicates "no pain/discomfort" and 100 indicates "the most severe pain/discomfort."
• 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.
• Ocular Surface Staining (OSS) is an examination in which dye is applied to the ocular surface to detect abnormalities on the eye's surface. This test is also performed by an ophthalmologist.
• The Schirmer test is a quantitative test used to measure tear volume over a period of 5 minutes.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention Group

The laser acupuncture and artificial tears therapy

Group Type: EXPERIMENTAL

The laser acupuncture and artificial tears therapy

Intervention Type: 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.

Control Group

The sham laser acupuncture and artificial tears therapy

Group Type: SHAM_COMPARATOR

The sham laser acupuncture and artificial tears therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Inria Chandra

Resident of Medical Acupuncture Study Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KPEK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

24-09-1470

Identifier Type: -

Identifier Source: org_study_id