Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)

Phase 2

Recruiting

• Conditions: Dry Eye Syndrome (DES); Laser Acupuncture; Sjögren's Syndrome (SS)

• Registration Number: NCT06780293
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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."

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 Timeline

• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Study Start: 2025-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	one year	Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).
Schirmer's test	one year	Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES).
Ocular Surface Disease Index (OSDI)	one year	Ocular Surface Disease Index (OSDI) is a tool to rate the severity of dry eye disease among the Dry eye syndrome (DES).

Secondary Outcome Measures

Name	Time	Method
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)	one year	EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is a tool for evaluating the symptoms of SJS among the Dry eye syndrome (DES).
Traditional Chinese Medicine (TCM) tongue diagnosis	one year	Traditional Chinese Medicine (TCM) tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES).
Traditional Chinese Medicine (TCM) pulse diagnosis	one year	Traditional Chinese Medicine (TCM) pulse diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES).
Traditional Chinese Medicine (TCM) constitution questionnaire	one year	Traditional Chinese Medicine (TCM) constitution questionnaire is a tool for detecting the constitution among the Dry eye syndrome (DES).
Traditional Chinese Medicine (TCM) heart rate variability analysis	one year	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).
Nailfold microcirculation assessment	one year	Nailfold microcirculation assessment is a tool for detecting the status of nailfold microcirculation among the Dry eye syndrome (DES).
Iris examination	one year	Iris examination is a tool for detecting the status of iris among the Dry eye syndrome (DES).

Trial Locations

Locations (1)

Ching-Mao Chang; 🇨🇳 Taipei, Taiwan