Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorTaipei Veterans General Hospital, Taiwan
About this trial
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."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged between 20 and 75 years
Schirmer's test less than 10 mm/5 min
Disqualifiers
Pregnancy
With eye inflammation or infectious eye disease
Accepted operation of eye
Sjögren's syndrome
Trial design
Design model
Parallel
Treatments tested in this trial
Laser acupuncture (LA)
Other interventionThe 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.
Numerical Rating Scale (NRS)
Diagnostic testLA+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).
Schirmer's test
Diagnostic testLA+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.
Ocular Surface Disease Index (OSDI)
Diagnostic testLA+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.
EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
Diagnostic testLA+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.
Traditional Chinese Medicine (TCM) tongue diagnosis
Diagnostic testLA+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.
Traditional Chinese Medicine (TCM) pulse diagnosis
Diagnostic testLA+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.
Traditional Chinese Medicine (TCM) constitution questionnaire
Diagnostic testLA+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.
Traditional Chinese Medicine (TCM) heart rate variability analysis
Diagnostic testLA+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.
nailfold microcirculation assessment
Diagnostic testLA+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.
iris examination
Diagnostic testLA+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 Laser Acupuncture
Other interventionThe 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.
Treatment groups
140 Participants
are divided into 5 treatment groupsGroup A: LA+LA group of SJS-DESExperimental treatment 11 interventions
Group B: Sham+LA group of SJS-DESSham comparator 12 interventions
Group C: LA+LA group of Non-SJS-DESExperimental treatment 11 interventions
Group D: Sham+LA group of Non-SJS-DESSham comparator 12 interventions
Group E: Waiting listOther 10 interventions
Trial outcomes
Primary outcomes
1
Numerical Rating Scale (NRS)
Numerical Rating Scale (NRS) is a tool for evaluating pain among the Dry eye syndrome (DES).
Time frame
one year2
Schirmer's test
Schirmer's test is a tool for evaluating aqueous tear production among the Dry eye syndrome (DES).
Time frame
one year3
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).
Time frame
one yearSecondary outcomes
1
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).
Time frame
one year2
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).
Time frame
one year3
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).
Time frame
one year4
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).
Time frame
one yearSponsors and contacts
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Source ClinicalTrials.gov