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Completed

NCT Number: NCT06688630

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The Ocular Surface Disease Index

    Time frame: Before therapy, week 2, week 4

    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.

  2. The Tear Break-up Time

    Time frame: Before therapy, week 2, week 4

    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.

Secondary outcomes

  1. The Ocular Surface Staining Score

    Time frame: Before therapy, week 2, week 4

    Ocular Surface Staining (OSS) score is a scoring of examination in which dye is applied to the ocular surface to detect abnormalities on the eye's surface.

  2. The Schirmer Score

    Time frame: Before therapy, week 2, week 4

    The Schirmer score is an accumulation of tear volume over a period of 5 minutes.

  3. The Visual Analog Scale

    Time frame: Before therapy, week 2, week 4

    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."

  4. Adverse Event

    Time frame: Up to week 4

    Symptoms reported by patients after receiving laser acupuncture therapy.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

The Effect of Laser Acupuncture on the Signs and Symptoms of Dry Eye Disease Due to Visual Display Terminal Use

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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