Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)
LADESJS
Exploring the Long-term Therapeutic Effects of Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms
1 other identifier
interventional
140
1 country
1
Brief Summary
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture treatment). Each session will target the Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints bilaterally, performed twice a week. The total study period is 8 weeks, and the treatment efficacy will be assessed at the end of the 8-week treatment. The Waiting List group (20 participants) will not receive any laser acupuncture treatment during this period. Efficacy will be evaluated using the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination. This study aims to investigate the impact of laser acupuncture on dry eye symptom improvement and the potential markers that differentiate between SJS-DES and Non-SJS-DES patients. The goal is to develop a comprehensive integrated care model for early screening, diagnosis, and personalized treatment plans for Dry Eye Syndrome and Sjögren's Syndrome, achieving the ultimate objective of "Holistic Health Care."
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2025
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2025
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 9, 2025
April 1, 2025
3 months
January 13, 2025
April 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).
one year
Schirmer's test
Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES).
one year
Ocular Surface Disease Index (OSDI)
Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES).
one year
Secondary Outcomes (7)
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
one year
Traditional Chinese Medicine (TCM) tongue diagnosis
one year
Traditional Chinese Medicine (TCM) pulse diagnosis
one year
Traditional Chinese Medicine (TCM) constitution questionnaire
one year
Traditional Chinese Medicine (TCM) heart rate variability analysis
one year
- +2 more secondary outcomes
Study Arms (5)
LA+LA group of SJS-DES
EXPERIMENTALLA+LA group of SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.
Sham+LA group of SJS-DES
SHAM COMPARATORSham+LA group of SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.
LA+LA group of Non-SJS-DES
EXPERIMENTALLA+LA group of Non-SJS-DES will receive laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.
Sham+LA group of Non-SJS-DES
SHAM COMPARATORSham+LA group of Non-SJS-DES will receive sham acupuncture twice a week 4 weeks and then laser acupuncture at acupoint GB20, BL2, LI4 and LI11 twice a week 4 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.
Waiting list
OTHERGroup Waiting list will not receive any treatment at acupoint GB20, BL2, LI4 and LI11 twice a week 8 weeks for efficacy evaluation. And we could use the Numerical Rating Scale (NRS), Schirmer's test, Ocular Surface Disease Index (OSDI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, TCM constitution questionnaire, TCM heart rate variability analysis, nailfold microcirculation assessment, and iris examination for this purpose.
Interventions
The RJ-Laser acupuncture device (Reimers \& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Numerical Rating Scale (NRS).
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Schirmer's test.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the OSDI test.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the ESSPRI.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) tongue diagnosis.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) pulse diagnosis.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) constitution questionnaire.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the Traditional Chinese Medicine (TCM) heart rate variability analysis.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the nailfold microcirculation assessment.
LA+LA group of SJS-DES, Sham+LA group of SJS-DES, LA+LA group of Non-SJS-DES, Sham+LA group of Non-SJS-DES and Waiting list will take the iris examination.
The RJ-Laser acupuncture device (Reimers \& Janssen GmbH, Waldkirch, Germany) is used with a laser wavelength of 810 nm (infrared). The Bahr frequency B3 is set at 2398 Hz, with an energy output of 400 mW, operating in intermittent pulse mode. Each acupoint is irradiated for 15 seconds. A total of 8 bilateral acupoints are treated per session, with a total treatment time of approximately 120 seconds. The sham laser acupuncture procedure follows the same process as the true laser acupuncture protocol, including the positioning, cleaning of acupoints, and wearing of protective goggles. However, no laser emission is delivered during the treatment. This ensures a consistent experience for the patient while maintaining the blinding integrity of the study.
Eligibility Criteria
You may qualify if:
- aged between 20 and 75 years
- Schirmer's test less than 10 mm/5 min
You may not qualify if:
- Pregnancy
- With eye inflammation or infectious eye disease
- Accepted operation of eye
- Sjögren's syndrome
- primary or secondary SS
- aged between 20 and 75 years
- fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
- had no abnormal findings of immune, liver, kidney, or blood function evaluations.
- a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
- pregnancy or breastfeeding
- steroid pulse therapy within three months prior to the commencement of our study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ching-Mao Chang
Taipei, Taiwan, 886, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The randomization process will be conducted by a statistical expert using permuted block randomization to generate a "Clinical Trial Randomized Allocation Table." The allocation details will be sealed in envelopes to ensure blinding. Additionally, individual decoding envelopes will be prepared for each participant to allow emergency unblinding without compromising the trial's integrity. The randomization table and grouping details will be securely stored by the statistical expert and the principal investigator, while the individual decoding envelopes will be kept exclusively by the principal investigator.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Division of Integrative Medicine, Center for Traditional Medicine
Study Record Dates
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
February 3, 2025
Primary Completion
April 30, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
April 9, 2025
Record last verified: 2025-04