Back to resultsTraditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized Controlled Trial
Primary Purpose
Dry Eye Syndromes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)
TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)
TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)
Placebo TCM ultrasonic atomization treatment (PA)
Artificial Tears (AT)
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Dry Eye Syndromes, Traditional Chinese Medicine, Ultrasonic Atomization, Randomized Controlled Trial
Eligibility Criteria
Inclusion criteria: At least one eye of subjects meets DED diagnostic criteria as the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and Ocular Surface Disease Index (OSDI)≥13 and <33; and The age range between years 18-80, no sex limitation; and Symptoms of dry eye for at least 6 months; and Can complete the questionnaires independently and understand Chinese or English. Exclusion criteria: Had or currently suffering from other concomitant ocular surface diseases, including chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, and severe ocular allergy; Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months; Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol; Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months; Received topical antiglaucomatous treatment in the past 12 months Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment; Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases; Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD); Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation; Has adverse reaction history to herbs used in this study before; Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment; Pregnancy, preparation for pregnancy, or lactation;
Sites / Locations
- The Chinese University of Hong Kong Eye Centre (CUHKEC)
- Hong Kong Eye Hospital
- The CUHK Medical Centre (CUHKMC)
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Experimental
Placebo Comparator
Active Comparator
Arm Label
Compound Decoction (CD) group
Dendrobii Caulis (DC) group
Houttuynia Cordata (HC) group
Placebo Atomization (PA) group
Artificial Tears (AT) group
Arm Description
Outcomes
Primary Outcome Measures
Change in the Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity.
The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED(normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Change in Non-invasive Tear Break-up Times (NIBUT)
The non-invasive tear break-up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany). Subjects will be instructed to keep their eyes on as much as possible during the examination. First and average NIBUT will be recorded by the machine accordingly.
Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
Secondary Outcome Measures
Change in Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity.
The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED: normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Change in symptom Assessment iN Dry Eye (SANDE, modified)
Symptom Assessment iN Dry Eye (SANDE) questionnaire is a 2-item frequency- and severity-based visual analog scale. It is self-administered to evaluate the frequency and severity of dry eye symptoms.
The final SANDE score is calculated by obtaining the square root of the product of the frequency of symptoms score and the severity of symptoms score, with a range from 0 (minimal degree of dry eye symptoms) to 100 (maximal degree of dry eye symptoms)
Change in 36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey (SF-36) is a 36-item self-administered questionnaire, with 8 domains included: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The physical health sub-scale and Mental health sub-scale will be graded respectively.
Change in the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
The Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI: GH) is a 6-item questionnaire that measures impairments in work and activities.
Change in Non-Invasive Tear Break Up Times (NIBUT)
Non-Invasive tear break up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany) in both eyes. Participants were instructed to keep their eyes on as much as possible during the examination. First and average NIKBUTs will be recorded by the machine.
Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
Changes in Tear Meniscus Height (TMH)
The tear meniscus height (TMH) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany).
Changes in Bulbar Redness
Bulbar conjunctival hyperaemia is automatically evaluated the Keratograph 5M (OCULUS, Wetzlar, Germany) according to the JENVIS grading scale from 0 to 4.
Changes in Lipid Layer Thickness
The lipid layer thickness (LLT) of the tear film will be determined with the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC). Minimum, Maximum, and Average thickness in nanometers (nm) will be measured.
Changes in Partial Blinking Rate
The partial blinking rate will be reported as the percentage of incomplete blinks. The total and partial blinking times will be automatically recorded by the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC).
Changes in Meiboscore
The meiboscore grading will be based on the infrared meibography captured by the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC). Both superior and inferior eyelids will be recorded. The result will be graded by a masked assessor.
The grading scheme is a 3-point scale (grade 0, no meibomian gland atrophy; grade 1, less than 1/3 area of glands lost; grade 2, 1/3-2/3 area of glands lost; grade 3, more than 2/3 area of glands lost)
Change in Tear Film Breakup Time (TBUT)
The tear film breakup time (TBUT) is the time of the initial breakup of the tear film after a full blink. 2% Sodium fluorescein will be instilled in both eyes of the subjects. A masked follow-up assessor will do the examination via the slit lamp with a blue cobalt light. The TBUT will be measured three times with a stopwatch and taken on average.
Change in Corneal and Conjunctival Fluorescein Staining
Fluorescein sodium liquid will be instilled on the ocular surface. After 3 minutes, the corneal and conjunctival punctate epithelial erosions will be observed and graded via the slit lamp biomicroscope with a blue cobalt light.
The Oxford Grading System is selected for grading. The severity will be divided into 6 grades (Grade 0, absent; Grade 1, minimal; Grade 2, mild; Grade 3, moderate; Grade 4, marked; Grade 5, severe)
Change in Expressibility of Meibomian Glands in the Meibomian Glands Yielding Liquid Secretion (MGYLS) (the inferior eyelid)
Expressibility of the inferior eyelid meibomian glands is assessed with the Meibomian Gland Evaluator (TearScience, North Carolina, USA) applied inferior to central aspects of the inferior eyelid margin. The result is graded by a masked assessor.
The meibomian glands yielding liquid secretion (MGYLS) is the total number of glands that yield lipid secretions at the central aspects of the eyelid margin.
Change in Quality of Expressed Meibum
The meibomian gland evaluator will be applied to the central aspects of the inferior eyelid margin. The result will be graded by a masked assessor.
Each gland in each area will be assessed for expressibility and graded according to a 4-point scale: grade 0, no secretion; grade 1, inspissated/ toothpaste-like expression; grade 2, cloudy fluid secretion; and grade 3, clear fluid/normal secretion. The sum scores of 5 glands will be between 0 and 15.
Change in Lid Margin and Eyelash Abnormalities
Lid margin and eyelash abnormalities will be accessed by a slit lamp, including telangiectasia, meibomian gland capping, Demodex lash cylindrical collarettes, staphylococcal lash crusting, and seborrheic lash crusting.
All items will be graded based on a four-point scale: grade 0, absent; grade 1, mild; grade 2, moderate; grade 3, severe.
Change in Tear Film Osmolarity (TFO)
The tear film osmolarity (TFO) is measured by the ScoutPro™ Osmolarity System (TearLab , San Diego, CA) via the disposable test card in both eyes.
The normal osmolarity was considered as lower than 308 mOsm/L in both eyes. A difference more than 8 mOsm/L between two eyes reflects the stability of the tear film.
Changes in Schirmer I test
The Schirmer I test (ST) will be performed by sterile standard filter paper strips without anesthesia. The filter paper strips will be gently put on the temporal side of both lower eyelids for 5 minutes. The wetting length by tears in each strip will be recorded in nanometers (mm) by a masked assessor.
The strips will be collected in sterile centrifuge tubes respectively for further laboratory tests.
Changes in Matrix metallopeptidase 9 (MMP-9)
The MMP-9 enzyme-linked immunosorbent assay (ELISA) development kit (Invitrogen, Carlsbad, CA)) will be applied for measurement of the concentration of MMP-9 in participants' tears.
Adverse events (AEs)
The adverse events (AEs) will be the number of incidents based on a checklist of symptoms, signs, and diseases by patients' reporting, slit-lamp examination, or doctor's diagnosis.
Full Information
NCT ID
NCT06089317
First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT06089317
Brief Title
Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized Controlled Trial
Official Title
Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized, Double-masked, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Dry eye disease (DED) is the most prevalent ocular surface disease worldwide. Standard treatments like artificial tears show limited effect. Regarding the ultrasonic atomization, the ultrasonic nebulizer produces consistent steam from the solution with a treatment effect delivered to the ocular surface. We aim to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) ultrasonic atomization as an adjuvant treatment for DED.
This is a randomized double-masked, active- and placebo-controlled trial. 200 subjects will be equally assigned to the herbal compound decoction(CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization(PA) group, and artificial tear (AT) group by stratified permuted block randomization.
Subjects of CD, DC, HC, and PA groups will receive TCM ultrasonic atomization treatment (6 times/week). All patients will receive hypromellose 0.3% w/v lubricant eye drops for a 1-week wash-out and a 4-month follow-up period. Outcomes included non-invasive tear break-up times, corneal and conjunctival fluorescein staining, and other dry eye-related parameter examined by LipiView II Ocular Surface Interferometer, OCULUS® Keratograph 5M, and slit lamp biomicroscope evaluated by masked clinical assessors at baseline, week 1, 2, 3, 4 and month 2, 3, 4. The other subjective questionnaires like the Ocular Surface Disease Index (OSDI) questionnaire are also selected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Dry Eye Syndromes, Traditional Chinese Medicine, Ultrasonic Atomization, Randomized Controlled Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 200 subjects with mild to moderate DED will be recruited. Only one eye of recruited subjects with the shorter NIBUT will be selected and analyzed as the study eye. The subjects will be randomly divided into TCM compound decoction (CD) group, dendrobium caulis (DC) group, houttuynia cordata (HC) group, placebo atomization (PA) group, and artificial tears (AT) group equally. An online-based clinical trial randomization tool with a permuted block and stratification randomization method is applied for the randomization, and block sizes are randomly chosen. Stratification variances is sex and age.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compound Decoction (CD) group
Arm Type
Experimental
Arm Title
Dendrobii Caulis (DC) group
Arm Type
Active Comparator
Arm Title
Houttuynia Cordata (HC) group
Arm Type
Experimental
Arm Title
Placebo Atomization (PA) group
Arm Type
Placebo Comparator
Arm Title
Artificial Tears (AT) group
Arm Type
Active Comparator
Intervention Type
Combination Product
Intervention Name(s)
TCM ultrasonic atomization treatment with herbal Compound Decoction (CD)
Intervention Description
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the CD group is TCM compound decoction.
The prescription of atomization solution in the CD group contains Honeysuckle flower (金銀花) 5g, Chrysanthemum flower (菊花) 5g, Pale betterflybush flower (密蒙花) 5g, Mild mint herb (薄荷) 5g, Barbary wolfberry fruit (枸杞子) 10g, and Ophiopogon japonicus (麥冬) 5g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Intervention Type
Combination Product
Intervention Name(s)
TCM ultrasonic atomization treatment with Dendrobii Caulis (DC)
Intervention Description
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the DC group is Dendrobii Caulis extracts.
The prescription of the DC group contains Dendrobium (石斛) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Intervention Type
Combination Product
Intervention Name(s)
TCM ultrasonic atomization treatment with Houttuynia Cordata (HC)
Intervention Description
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the HC group is Heartleaf Houttuynia Herb extracts.
The prescription of the HC group contains Heartleaf Houttuynia Herb(魚腥草) 35g.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Intervention Type
Combination Product
Intervention Name(s)
Placebo TCM ultrasonic atomization treatment (PA)
Intervention Description
The subjects will receive TCM ultrasonic atomization treatment with the ultrasonic nebulizer (WH-2000, YueHua, China) 6 days a week, once daily, 10 minutes per session, for 4 weeks. The solution for atomization of the PA group is low-concentration compound decoction (5%) same with the CD group.
Subjects will be treated with hypromellose 0.3% w/v eye drops four times per day too.
Intervention Type
Drug
Intervention Name(s)
Artificial Tears (AT)
Intervention Description
The subjects will receive lubricant eye drop (Hypromellose 0.3% w/v Eye Drops) four times per day only.
Primary Outcome Measure Information:
Title
Change in the Ocular Surface Disease Index (OSDI)
Description
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity.
The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED(normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Time Frame
baseline to 4th week
Title
Change in Non-invasive Tear Break-up Times (NIBUT)
Description
The non-invasive tear break-up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany). Subjects will be instructed to keep their eyes on as much as possible during the examination. First and average NIBUT will be recorded by the machine accordingly.
Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
Time Frame
baseline to 4th week
Secondary Outcome Measure Information:
Title
Change in Ocular Surface Disease Index (OSDI)
Description
The Ocular Surface Disease Index (OSDI) is a 12-item symptom frequency-based questionnaire. It is self-administered to assess DED-related symptoms and severity.
The final OSDI score is calculated by dividing the product of the total sum of the score and 25 by the total number of answered questions, with a range from 0 to 100. The score reflects the severity of DED: normal: 0-12, mild: 13-22, moderate: 23-32, severe: >33).
Time Frame
4 months
Title
Change in symptom Assessment iN Dry Eye (SANDE, modified)
Description
Symptom Assessment iN Dry Eye (SANDE) questionnaire is a 2-item frequency- and severity-based visual analog scale. It is self-administered to evaluate the frequency and severity of dry eye symptoms.
The final SANDE score is calculated by obtaining the square root of the product of the frequency of symptoms score and the severity of symptoms score, with a range from 0 (minimal degree of dry eye symptoms) to 100 (maximal degree of dry eye symptoms)
Time Frame
4 months
Title
Change in 36-Item Short Form Health Survey (SF-36)
Description
The 36-Item Short Form Health Survey (SF-36) is a 36-item self-administered questionnaire, with 8 domains included: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The physical health sub-scale and Mental health sub-scale will be graded respectively.
Time Frame
4 months
Title
Change in the Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI:GH)
Description
The Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI: GH) is a 6-item questionnaire that measures impairments in work and activities.
Time Frame
4 months
Title
Change in Non-Invasive Tear Break Up Times (NIBUT)
Description
Non-Invasive tear break up time (NIBUT) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany) in both eyes. Participants were instructed to keep their eyes on as much as possible during the examination. First and average NIKBUTs will be recorded by the machine.
Shortening NIBUT(< 10 seconds) suggests instability of the tear film.
Time Frame
4 months
Title
Changes in Tear Meniscus Height (TMH)
Description
The tear meniscus height (TMH) will be measured by the OCULUS Keratograph® 5M (Oculus, Wetzlar, Germany).
Time Frame
4 months
Title
Changes in Bulbar Redness
Description
Bulbar conjunctival hyperaemia is automatically evaluated the Keratograph 5M (OCULUS, Wetzlar, Germany) according to the JENVIS grading scale from 0 to 4.
Time Frame
4 months
Title
Changes in Lipid Layer Thickness
Description
The lipid layer thickness (LLT) of the tear film will be determined with the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC). Minimum, Maximum, and Average thickness in nanometers (nm) will be measured.
Time Frame
4 months
Title
Changes in Partial Blinking Rate
Description
The partial blinking rate will be reported as the percentage of incomplete blinks. The total and partial blinking times will be automatically recorded by the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC).
Time Frame
4 months
Title
Changes in Meiboscore
Description
The meiboscore grading will be based on the infrared meibography captured by the LipiView ® II Ocular Surface Interferometer (TearScience, Morrisville, NC). Both superior and inferior eyelids will be recorded. The result will be graded by a masked assessor.
The grading scheme is a 3-point scale (grade 0, no meibomian gland atrophy; grade 1, less than 1/3 area of glands lost; grade 2, 1/3-2/3 area of glands lost; grade 3, more than 2/3 area of glands lost)
Time Frame
4 months
Title
Change in Tear Film Breakup Time (TBUT)
Description
The tear film breakup time (TBUT) is the time of the initial breakup of the tear film after a full blink. 2% Sodium fluorescein will be instilled in both eyes of the subjects. A masked follow-up assessor will do the examination via the slit lamp with a blue cobalt light. The TBUT will be measured three times with a stopwatch and taken on average.
Time Frame
4 months
Title
Change in Corneal and Conjunctival Fluorescein Staining
Description
Fluorescein sodium liquid will be instilled on the ocular surface. After 3 minutes, the corneal and conjunctival punctate epithelial erosions will be observed and graded via the slit lamp biomicroscope with a blue cobalt light.
The Oxford Grading System is selected for grading. The severity will be divided into 6 grades (Grade 0, absent; Grade 1, minimal; Grade 2, mild; Grade 3, moderate; Grade 4, marked; Grade 5, severe)
Time Frame
4 months
Title
Change in Expressibility of Meibomian Glands in the Meibomian Glands Yielding Liquid Secretion (MGYLS) (the inferior eyelid)
Description
Expressibility of the inferior eyelid meibomian glands is assessed with the Meibomian Gland Evaluator (TearScience, North Carolina, USA) applied inferior to central aspects of the inferior eyelid margin. The result is graded by a masked assessor.
The meibomian glands yielding liquid secretion (MGYLS) is the total number of glands that yield lipid secretions at the central aspects of the eyelid margin.
Time Frame
4 months
Title
Change in Quality of Expressed Meibum
Description
The meibomian gland evaluator will be applied to the central aspects of the inferior eyelid margin. The result will be graded by a masked assessor.
Each gland in each area will be assessed for expressibility and graded according to a 4-point scale: grade 0, no secretion; grade 1, inspissated/ toothpaste-like expression; grade 2, cloudy fluid secretion; and grade 3, clear fluid/normal secretion. The sum scores of 5 glands will be between 0 and 15.
Time Frame
4 months
Title
Change in Lid Margin and Eyelash Abnormalities
Description
Lid margin and eyelash abnormalities will be accessed by a slit lamp, including telangiectasia, meibomian gland capping, Demodex lash cylindrical collarettes, staphylococcal lash crusting, and seborrheic lash crusting.
All items will be graded based on a four-point scale: grade 0, absent; grade 1, mild; grade 2, moderate; grade 3, severe.
Time Frame
4 months
Title
Change in Tear Film Osmolarity (TFO)
Description
The tear film osmolarity (TFO) is measured by the ScoutPro™ Osmolarity System (TearLab , San Diego, CA) via the disposable test card in both eyes.
The normal osmolarity was considered as lower than 308 mOsm/L in both eyes. A difference more than 8 mOsm/L between two eyes reflects the stability of the tear film.
Time Frame
4 months
Title
Changes in Schirmer I test
Description
The Schirmer I test (ST) will be performed by sterile standard filter paper strips without anesthesia. The filter paper strips will be gently put on the temporal side of both lower eyelids for 5 minutes. The wetting length by tears in each strip will be recorded in nanometers (mm) by a masked assessor.
The strips will be collected in sterile centrifuge tubes respectively for further laboratory tests.
Time Frame
4 months
Title
Changes in Matrix metallopeptidase 9 (MMP-9)
Description
The MMP-9 enzyme-linked immunosorbent assay (ELISA) development kit (Invitrogen, Carlsbad, CA)) will be applied for measurement of the concentration of MMP-9 in participants' tears.
Time Frame
4 months
Title
Adverse events (AEs)
Description
The adverse events (AEs) will be the number of incidents based on a checklist of symptoms, signs, and diseases by patients' reporting, slit-lamp examination, or doctor's diagnosis.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Intraocular Pressure (IOP)
Description
The intraocular pressure of the eyes will be assessed by a non-contact tonometer.
Time Frame
4 months
Title
Best Corrected Visual Acuity (BCVA)
Description
Best corrected visual acuity (BCVA) is examined by a standard visual acuity chart.
Time Frame
4 months
Title
Change in Posterior Subcapsular of Lens
Description
The Lens Opacities Classification Systems (LOCS III) will be applied for lens grading.
The posterior subcapsular (P) cataract will be graded referring to five retroillumination images: P1-P5.
Time Frame
4 months
Title
Change in Nuclear Color (NC) of Lens
Description
The Lens Opacities Classification Systems (LOCS III) will be applied for lens grading.
Nuclear color (NC) will be graded referring to referring to six slit-lamp images: NC1-NC6.
Time Frame
4 months
Title
Change in Cortical Cataract (C) of Lens
Description
The Lens Opacities Classification Systems (LOCS III) will be applied for lens grading.
Cortical cataract (C) will be graded referring to five retroillumination images: C1-C5.
Time Frame
4 months
Title
Change in Nuclear Opalescence (NO) of Lens
Description
The Lens Opacities Classification Systems (LOCS III) will be applied for lens grading.
Nuclear opalescence (NO) will be graded referring to six slit-lamp images: NO01-NO06.
Time Frame
4 months
Title
Change in Central Corneal Thickness (CCT) of Corneal Endothelium
Description
Central corneal thickness will be measured with a non-contact specular microscope (Nidek CEM-530, NIDEK Co., Ltd. Japan).
Time Frame
4 months
Title
Change in Corneal Endothelial Cell Density (CD) of Corneal Endothelium
Description
Corneal endothelial cell density will be measured with a non-contact specular microscope (Nidek CEM-530, NIDEK Co., Ltd. Japan).
Time Frame
4 months
Title
Change in Number of Cells Counted (NUM) of Corneal Endothelium
Description
Number of cells counted will be measured with a non-contact specular microscope (Nidek CEM-530, NIDEK Co., Ltd. Japan).
Time Frame
4 months
Title
Constitution in Chinese Medicine Questionnaire (CCMQ)
Description
Constitution in Chinese Medicine Questionnaire (CCMQ) is a self-administered questionnaire with 60 items. It will be applied to classify a person's traditional Chinese medicine constitution out of 9 pre-defined types.
Time Frame
-1 week
Title
Change of α-diversity in Ocular Surface Microbiome
Description
Each eye will be sampled by a sterile, polyester swab on the inferior fornix of the conjunctiva. The swabs will be placed in 2 mL microcentrifuge tubes at 4 °C. Extraction will be performed by laboratory staff, then the sample will be transferred to -80 °C laboratory freezer for long-term storage before further gene expression tests. After genomic DNA extraction from conjunctival swab samples for 16S rRNA sequencing, the resulting amplicons will be filtered, clustered into operational taxonomic units (OTUs) and taxonomically classified using reference databases. The α-diversity will be calculated and reported as ordination plots.
Time Frame
4 months
Title
Change of β-diversity in Ocular Surface Microbiome
Description
Each eye will be sampled by a sterile, polyester swab on the inferior fornix of the conjunctiva. The swabs will be placed in 2 mL microcentrifuge tubes at 4 °C. Extraction will be performed by laboratory staff, then the sample will be transferred to -80 °C laboratory freezer for long-term storage before further gene expression tests. After genomic DNA extraction from conjunctival swab samples for 16S rRNA sequencing, the resulting amplicons will be filtered, clustered into operational taxonomic units (OTUs) and taxonomically classified using reference databases. The β-diversity will be calculated and reported as ordination plots.
Time Frame
4 months
Title
Relative Abundance in Ocular Surface Microbiome
Description
Each eye will be sampled by a sterile, polyester swab on the inferior fornix of the conjunctiva. The swabs will be placed in 2 mL microcentrifuge tubes at 4 °C. Extraction will be performed by laboratory staff, then the sample will be transferred to -80 °C laboratory freezer for long-term storage before further gene expression tests. After genomic DNA extraction from conjunctival swab samples for 16S rRNA sequencing, the resulting amplicons will be filtered, clustered into operational taxonomic units (OTUs) and taxonomically classified using reference databases. The relative abundance will be reported.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
At least one eye of subjects meets DED diagnostic criteria as the Tear Film and Ocular Surface Society (TFOS) Dry Eye Workshop (DEWS II); and
Ocular Surface Disease Index (OSDI)≥13 and <33; and
The age range between years 18-80, no sex limitation; and
Symptoms of dry eye for at least 6 months; and
Can complete the questionnaires independently and understand Chinese or English.
Exclusion criteria:
Had or currently suffering from other concomitant ocular surface diseases, including chronic conjunctivitis, ocular rosacea, cicatricial pemphigoid, graft-versus-host disease, limbal stem cell deficiency, and severe ocular allergy;
Received any refractive surgery and corneal surgery before, including corneal transplant; or any eye surgery in the past 6 months;
Receiving DED-related medications, including topical steroid eyedrops, topical antibiotics, topical cyclosporin A, and topical diquafosol;
Received intense pulsed laser (IPL) or vectored thermal pulsation (VTP) therapy in the past 12 months;
Received topical antiglaucomatous treatment in the past 12 months
Plans to use contact lenses during treatment and follow-up periods or used contact lenses 2 weeks before the baseline measurement and recruitment;
Had or currently suffering from severe cardiopulmonary disease, liver and kidney dysfunction, and severe blood system diseases;
Suffering from glucose-6-phosphate dehydrogenase deficiency (G6PD);
Had or currently suffering from specific respiratory diseases, e.g. emphysema, bronchitis, asthma, chronic obstructive pulmonary disease, bronchial dilatation;
Has adverse reaction history to herbs used in this study before;
Whose TCM constitution is manifested as "yang-deficiency" or diagnosed by TCM practitioners that their TCM syndrome is not suitable for the atomization treatment;
Pregnancy, preparation for pregnancy, or lactation;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Tsoi
Phone
3943 5818
Ext
+852
Email
jennifertsoi@cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Kelvin KL Chong, MBChB
Phone
3943 5805
Ext
+852
Email
chongkamlung@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelvin KL Chong, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong Eye Centre (CUHKEC)
City
Kowloon
ZIP/Postal Code
000000
Country
Hong Kong
Facility Name
Hong Kong Eye Hospital
City
Kowloon
Country
Hong Kong
Facility Name
The CUHK Medical Centre (CUHKMC)
City
Shatin
ZIP/Postal Code
000 000
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
000000
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Traditional Chinese Medicine Ultrasonic Atomization Treatment for Dry Eye Disease: A Randomized Controlled Trial
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