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

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."

Study Overview

• Status: Recruiting
• Conditions: Laser Acupuncture; Dry Eye Syndrome (DES); Sjögren's Syndrome (SS)
• Intervention / Treatment: Other: Laser acupuncture (LA); Diagnostic test: Numerical Rating Scale (NRS); Diagnostic test: Schirmer's test; Diagnostic test: Ocular Surface Disease Index (OSDI); Diagnostic test: EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI); Diagnostic test: Traditional Chinese Medicine (TCM) tongue diagnosis; Diagnostic test: Traditional Chinese Medicine (TCM) pulse diagnosis; Diagnostic test: Traditional Chinese Medicine (TCM) constitution questionnaire; Diagnostic test: Traditional Chinese Medicine (TCM) heart rate variability analysis; Diagnostic test: nailfold microcirculation assessment; Diagnostic test: iris examination; Other: Sham Laser Acupuncture

Detailed Description

Method: 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."

Expected Results:

1. Assess the therapeutic differences between Sham+LA and LA+LA groups in the SJS-DES population.
2. Assess the therapeutic differences between Sham+LA and LA+LA groups in the Non-SJS-DES population.
3. Evaluate the therapeutic differences between the SJS-DES and Non-SJS-DES populations.

Keywords: Dry eye syndrome, Sjögren's syndrome, Laser Acupuncture, GB20, BL2, LI4, LI11

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ching-Mao Chang, M.D., Ph.D.; Phone Number: 886-28757453, 333; Email: magicbjp@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 886
    • Recruiting
    • Ching-Mao Chang
    • Contact: Ching-Mao Chang, M.D., Ph.D.; Phone Number: 333 88628757453; Email: magicbjp@gmail.com
    • Contact: Ching-Mao Chang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Dry eye syndrome

Inclusion Criteria:

1. aged between 20 and 75 years
2. Schirmer's test less than 10 mm/5 min

Exclusion Criteria:

1. Pregnancy
2. With eye inflammation or infectious eye disease

3. Accepted operation of eye

   • Sjögren's syndrome

Inclusion Criteria:

1. primary or secondary SS
2. aged between 20 and 75 years
3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
4. had no abnormal findings of immune, liver, kidney, or blood function evaluations.

Exclusion Criteria:

1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
2. pregnancy or breastfeeding
3. steroid pulse therapy within three months prior to the commencement of our study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LA+LA group of SJS-DES; LA+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.	Other: Laser acupuncture (LA); 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.; Diagnostic test: 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 Numerical Rating Scale (NRS).; Diagnostic test: 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 Schirmer's test.; Diagnostic test: Ocular Surface Disease Index (OSDI); 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.; Diagnostic test: EULAR Sjögren's Syndrome Patient Reported Index (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 ESSPRI.; Diagnostic test: 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) tongue diagnosis.; Diagnostic test: 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) pulse diagnosis.; Diagnostic test: 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) constitution questionnaire.; Diagnostic test: 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 Traditional Chinese Medicine (TCM) heart rate variability analysis.; Diagnostic test: 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 nailfold microcirculation assessment.; Diagnostic test: iris examination; 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.
Sham Comparator: Sham+LA group of SJS-DES; Sham+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.	Other: Laser acupuncture (LA); 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.; Diagnostic test: 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 Numerical Rating Scale (NRS).; Diagnostic test: 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 Schirmer's test.; Diagnostic test: Ocular Surface Disease Index (OSDI); 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.; Diagnostic test: EULAR Sjögren's Syndrome Patient Reported Index (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 ESSPRI.; Diagnostic test: 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) tongue diagnosis.; Diagnostic test: 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) pulse diagnosis.; Diagnostic test: 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) constitution questionnaire.; Diagnostic test: 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 Traditional Chinese Medicine (TCM) heart rate variability analysis.; Diagnostic test: 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 nailfold microcirculation assessment.; Diagnostic test: iris examination; 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.; Other: Sham Laser Acupuncture; 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.
Experimental: LA+LA group of Non-SJS-DES; LA+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.	Other: Laser acupuncture (LA); 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.; Diagnostic test: 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 Numerical Rating Scale (NRS).; Diagnostic test: 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 Schirmer's test.; Diagnostic test: Ocular Surface Disease Index (OSDI); 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.; Diagnostic test: EULAR Sjögren's Syndrome Patient Reported Index (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 ESSPRI.; Diagnostic test: 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) tongue diagnosis.; Diagnostic test: 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) pulse diagnosis.; Diagnostic test: 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) constitution questionnaire.; Diagnostic test: 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 Traditional Chinese Medicine (TCM) heart rate variability analysis.; Diagnostic test: 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 nailfold microcirculation assessment.; Diagnostic test: iris examination; 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.
Sham Comparator: Sham+LA group of Non-SJS-DES; Sham+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.	Other: Laser acupuncture (LA); 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.; Diagnostic test: 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 Numerical Rating Scale (NRS).; Diagnostic test: 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 Schirmer's test.; Diagnostic test: Ocular Surface Disease Index (OSDI); 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.; Diagnostic test: EULAR Sjögren's Syndrome Patient Reported Index (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 ESSPRI.; Diagnostic test: 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) tongue diagnosis.; Diagnostic test: 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) pulse diagnosis.; Diagnostic test: 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) constitution questionnaire.; Diagnostic test: 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 Traditional Chinese Medicine (TCM) heart rate variability analysis.; Diagnostic test: 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 nailfold microcirculation assessment.; Diagnostic test: iris examination; 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.; Other: Sham Laser Acupuncture; 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.
Other: Waiting list; Group 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.	Diagnostic test: 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 Numerical Rating Scale (NRS).; Diagnostic test: 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 Schirmer's test.; Diagnostic test: Ocular Surface Disease Index (OSDI); 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.; Diagnostic test: EULAR Sjögren's Syndrome Patient Reported Index (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 ESSPRI.; Diagnostic test: 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) tongue diagnosis.; Diagnostic test: 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) pulse diagnosis.; Diagnostic test: 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) constitution questionnaire.; Diagnostic test: 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 Traditional Chinese Medicine (TCM) heart rate variability analysis.; Diagnostic test: 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 nailfold microcirculation assessment.; Diagnostic test: iris examination; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)	EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a tool for evaluating the symptoms of SJS among the Dry eye syndrome (DES).	one year
Traditional Chinese Medicine (TCM) tongue diagnosis	Traditional Chinese Medicine (TCM) tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES).	one year
Traditional Chinese Medicine (TCM) pulse diagnosis	Traditional Chinese Medicine (TCM) pulse diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES).	one year
Traditional Chinese Medicine (TCM) constitution questionnaire	Traditional Chinese Medicine (TCM) constitution questionnaire is a tool for detecting the constitution among the Dry eye syndrome (DES).	one year
Traditional Chinese Medicine (TCM) heart rate variability analysis	Traditional Chinese Medicine (TCM) heart rate variability analysis is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES).	one year
Nailfold microcirculation assessment	Nailfold microcirculation assessment is a tool for detecting the status of nailfold microcirculation among the Dry eye syndrome (DES).	one year
Iris examination	Iris examination is a tool for detecting the status of iris among the Dry eye syndrome (DES).	one year

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Sjögren's syndrome; Dry eye syndrome; Laser Acupuncture; Fengchi (GB20); Zanzhu (BL2); Hegu (LI4); Quchi (LI11)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease; Eye Diseases; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Syndrome; Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 2024-11-008C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The decision to share individual participant data (IPD) is currently undecided due to ongoing discussions regarding data management, privacy concerns, and compliance with institutional and regulatory requirements. Additional considerations include the establishment of appropriate data-sharing agreements, ensuring participant confidentiality, and defining the scope and method of data access. Once these factors are thoroughly evaluated and addressed, a final decision regarding IPD sharing will be made in accordance with ethical guidelines and applicable regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No