Clinical Trials Directory

Trials / Completed

CompletedNCT06688630

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
18 Years – 59 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEThe laser acupuncture and artificial tears therapyLaser 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.
DEVICEThe sham laser acupuncture and artificial tears therapyLaser 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.

Timeline

Start date
2024-12-27
Primary completion
2025-03-14
Completion
2025-03-14
First posted
2024-11-14
Last updated
2025-03-19

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT06688630. Inclusion in this directory is not an endorsement.