Dry Eye SyndromesNCT06688630
Laser Acupuncture for Dry Eye Disease Due to Visual Display Terminal Use
A study testing The laser acupuncture and artificial tears therapy in people with Dry Eye Syndromes, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- The laser acupuncture and artificial tears therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Dec 2024to 14 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laser Acupuncture on the Signs and Symptoms of 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?
Read more
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.
Read the 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
- Being tested
- The laser acupuncture and artificial tears therapy, The sham laser acupuncture and artificial tears therapy
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The laser acupuncture and artificial tears therapyDevice
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 therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The laser acupuncture and artificial tears therapy Receives: Device: The laser acupuncture and artificial tears therapy |
| Control Group | Sham comparator | The sham laser acupuncture and artificial tears therapy Receives: Device: The sham laser acupuncture and artificial tears therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ocular Surface Disease Index
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.
Measured: Before therapy, week 2, week 4
The Tear Break-up Time
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.
Measured: Before therapy, week 2, week 4
Secondary outcomes (4)
The Ocular Surface Staining Score
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.
Measured: Before therapy, week 2, week 4
The Schirmer Score
The Schirmer score is an accumulation of tear volume over a period of 5 minutes.
Measured: Before therapy, week 2, week 4
The Visual Analog Scale
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."
Measured: Before therapy, week 2, week 4
Adverse Event
Symptoms reported by patients after receiving laser acupuncture therapy.
Measured: Up to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start27 Dec 2024
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inria Chandra, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688630
- Sponsor's protocol ID
- 24-09-1470
- Status last verified
- Mar 2025
- First submitted
- 12 Nov 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laser Acupuncture on the Signs and Symptoms of Dry Eye Disease Due to Visual Display Terminal Use
- ClinicalTrials.gov ID
- NCT06688630
- Acronym / sponsor ID
- 24-09-1470
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 27 Dec 2024 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: The laser acupuncture and artificial tears therapyThe laser acupuncture and artificial tears therapy |
| Control Group | Sham comparator | Device: The sham laser acupuncture and artificial tears therapyThe sham laser acupuncture and artificial tears therapy |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The 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. | Device | Intervention Group |
| The 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. | Device | Control Group |
Primary outcome
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.
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.
4 secondary outcomes
The Ocular Surface Staining Score
Time frame: Before therapy, week 2, week 4
The Schirmer Score
Time frame: Before therapy, week 2, week 4
The Visual Analog Scale
Time frame: Before therapy, week 2, week 4
Adverse Event
Time frame: Up to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The laser acupuncture and artificial tears therapy in people with Dry Eye Syndromes, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ocular Surface Disease Index (time frame: Before therapy, week 2, week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.