Clinical trial NCT06688630: Laser Acupuncture for Dry Eye Disease Due to Visual Display Terminal Use
Official title: The Effect of Laser Acupuncture on the Signs and Symptoms of Dry Eye Disease Due to Visual Display Terminal Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Ocular Surface Disease Index
timeFrame: Before therapy, week 2, week 4
measure: The Tear Break-up Time
timeFrame: Before therapy, week 2, week 4
Secondary outcomes:
measure: The Ocular Surface Staining Score
timeFrame: Before therapy, week 2, week 4
measure: The Schirmer Score
timeFrame: Before therapy, week 2, week 4
measure: The Visual Analog Scale
timeFrame: Before therapy, week 2, week 4
measure: Adverse Event
timeFrame: Up to week 4
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Universitas Indonesia
state: DKI Jakarta
Study officials:
affiliation: The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
name: KPEK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: