Dry EyeNCT03204903
Laser Acupuncture for Dry Eye
A study testing Laser acupuncture in people with Dry Eye, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Laser acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 31 Jul 2019
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 < age < 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.
- Tear film break-up time < 10 s
- Schirmer's strips with anesthesia < 5mm/ 5min
Who cannot join
- presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens
- pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis
- critical illness such as Stevens-Johnson syndrome, etc
- has taken or needs active treatment (including Chinese medicine)
- presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin
- does not meet the physician's assessment for recruitment
- lack of informed consent.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Wen-Long Hu, MD, MS, +886-7-7317123 ext. 6255, oolonghu@gmail.com
About this study
Official title: Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial
Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.
Read the detailed description
Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.
Methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
- Conditions
- Dry Eye
- Being tested
- Laser acupuncture, Sham laser acupuncture
- Keywords
- Dry eye, Laser acupuncture, Traditional Chinese medicine
- 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.
Laser acupunctureProcedure or surgery
Subjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.
Sham laser acupunctureProcedure or surgery
Subjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture | Experimental | The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using laser acupuncture during 3 sessions per week for 12 weeks. Receives: Procedure: Laser acupuncture |
| Sham laser acupuncture | Sham comparator | The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using sham laser acupuncture (without laser output) during 3 sessions per week for 12 weeks. Receives: Procedure: Sham laser acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index
The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision.
Measured: 12 weeks
Secondary outcomes (3)
Schirmer test
A Schirmer's test is used to assess how quickly the eyes produce tears.
Measured: 12 weeks
Visual analogue scale of eye discomfort
A 10-cm visual analog scale (0-10 points, least to greatest discomfort intensity, VAS) was used to measure the intensity of eye discomfort.
Measured: 12 weeks
Tear film break-up time
Tear film break-up time (TFBUT) measures the time required for tears to naturally evaporate and diffuse after blinking.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Aug 2016
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204903
- Sponsor's protocol ID
- CMRPG8F0551
- Other IDs
- 201600333A3
- Status last verified
- Aug 2018
- First submitted
- 21 May 2017
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, Kang KW, Jung SY, Kim AR, Kim TH. Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10.
PubMed 21070615Hu WL, Yu HJ, Pan LY, Wu PC, Pan CC, Kuo CE, Tseng YJ, Hung YC. Laser Acupuncture Improves Tear Film Stability in Patients with Dry Eye Disease: A Two-Center Randomized-Controlled Trial. J Altern Complement Med. 2021 Jul;27(7):579-587. doi: 10.1089/acm.2020.0524. Epub 2021 Apr 27.
PubMed 33904792Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.
PubMed 29851803
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03204903
- Acronym / sponsor ID
- CMRPG8F0551
- Conditions
- Dry Eye
- Keywords
- Dry eye, Laser acupuncture, Traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 2 Jul 2017 (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.
Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.
Detailed description
Objective: Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.
Methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture | Experimental | Procedure: Laser acupunctureThe subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using laser acupuncture during 3 sessions per week for 12 weeks. |
| Sham laser acupuncture | Sham comparator | Procedure: Sham laser acupunctureThe subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using sham laser acupuncture (without laser output) during 3 sessions per week for 12 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 < age < 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.
- Tear film break-up time < 10 s
- Schirmer's strips with anesthesia < 5mm/ 5min
Key exclusion criteria (7 listed)
- presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens
- pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis
- critical illness such as Stevens-Johnson syndrome, etc
- has taken or needs active treatment (including Chinese medicine)
- presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin
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 |
|---|---|---|
| Laser acupunctureSubjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37. | Procedure or surgery | Laser acupuncture |
| Sham laser acupunctureSubjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37. | Procedure or surgery | Sham laser acupuncture |
Primary outcome
Ocular Surface Disease Index
Time frame: 12 weeks
The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision.
3 secondary outcomes
Schirmer test
Time frame: 12 weeks
Visual analogue scale of eye discomfort
Time frame: 12 weeks
Tear film break-up time
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Background: PubMed 21070615Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, Kang KW, Jung SY, Kim AR, Kim TH. Acupuncture for treating dry eye: a randomized placebo-controlled trial. Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10.
- Derived from this study: PubMed 33904792Hu WL, Yu HJ, Pan LY, Wu PC, Pan CC, Kuo CE, Tseng YJ, Hung YC. Laser Acupuncture Improves Tear Film Stability in Patients with Dry Eye Disease: A Two-Center Randomized-Controlled Trial. J Altern Complement Med. 2021 Jul;27(7):579-587. doi: 10.1089/acm.2020.0524. Epub 2021 Apr 27.
- Derived from this study: PubMed 29851803Hu WL, Wu PC, Pan LY, Yu HJ, Pan CC, Hung YC. Effect of laser acupuncture on dry eye: A study protocol for a 2-center randomized controlled trial. Medicine (Baltimore). 2018 Jun;97(22):e10875. doi: 10.1097/MD.0000000000010875.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture in people with Dry Eye, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Aug 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-Long Hu, MD, MS (+886-7-7317123 ext. 6255, oolonghu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03204903, which also lists 3 linked publications.
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 3 Aug 2018.