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Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease

Primary Purpose

Dry Eye

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sodium hyaluronate eye drops
acupuncture
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring dry eye, pain, acupuncture

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
  • VAS>0;
  • Signed informed consent.

Exclusion Criteria:

  • Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
  • Eyeball infections, allergies, deformities, abnormal movements
  • Any history of eye surgery
  • Have had eye trauma or fundus laser treatment within 3 months
  • Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
  • Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.

Sites / Locations

  • Peking University Third Hospital
  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artificial tears

Acupuncture

Arm Description

Artificial tears

Acupuncture

Outcomes

Primary Outcome Measures

Visual Analogue Score
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset

Secondary Outcome Measures

OSDI
OSDI consists of 12 scoring items, divided into three parts: severity of symptoms, impact of symptoms on daily life, and impact of environment on symptoms.
TBUT
Drop 1 drop of 0.3% sodium fluorescein eye solution into the subject's conjunctival sac, dry it with a sterile cotton swab, and ask him to blink gently to make the fluorescein sodium evenly distributed. Observe the subject from the last time with a slit lamp cobalt blue light. The time from blinking to the first dark spot on the corneal surface, record three times and take the average
SIt
Fold one end of the special 5mm×35mm filter paper (Tianjin Jingming) for tears by 5mm, and gently place it on the middle and outer 1/3 of the subject's lower eyelid conjunctival sac, and the other end will droop naturally. Ask the subject to gently close their eyes for 5 minutes After measuring the length of the filter paper wetted by tears
CFS score
Divide the cornea into 5 quadrants (central + nose/temporal/upper/lower), each quadrant has a staining score of 0 to 3 points, and it is specified that no staining is 0 points, and 30 spots are stained as 1 point, and there is flaky staining and fusion 3 points for filament formation, 2 points between the two, the sum of 5 quadrants is the score of the entire cornea, and the CFS score of the entire cornea is 0-15 points.
Density and curvature of corneal subbasal nerve
Collect corneal subbasal nerve images, 2 images each in the upper, lower, arm, temporal and central areas. Use deep learning methods to analyze nerve density and curvature
Tear pain factor content
With the aid of a slit lamp, a capillary pipette was used to draw 5 μl tears/eye at the middle and outer edges of the lower eyelid 2/3 of the tear river, and placed in a low protein adhesion EP tube (containing 5 μl 1% BSA) and stored at -80°C. ELISA analyzes the protein levels of PGE2, substance P and NGF in tear fluid.

Full Information

First Posted
December 6, 2020
Last Updated
November 20, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04668131
Brief Title
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
Official Title
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 22, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
dry eye, pain, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial tears
Arm Type
Experimental
Arm Description
Artificial tears
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
Acupuncture
Intervention Type
Drug
Intervention Name(s)
Sodium hyaluronate eye drops
Other Intervention Name(s)
artificial tears
Intervention Description
eye drops, three times a day
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
three times a week
Primary Outcome Measure Information:
Title
Visual Analogue Score
Description
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset
Time Frame
The treatment period for each enrolled subject is one month
Secondary Outcome Measure Information:
Title
OSDI
Description
OSDI consists of 12 scoring items, divided into three parts: severity of symptoms, impact of symptoms on daily life, and impact of environment on symptoms.
Time Frame
The treatment period for each enrolled subject is one month
Title
TBUT
Description
Drop 1 drop of 0.3% sodium fluorescein eye solution into the subject's conjunctival sac, dry it with a sterile cotton swab, and ask him to blink gently to make the fluorescein sodium evenly distributed. Observe the subject from the last time with a slit lamp cobalt blue light. The time from blinking to the first dark spot on the corneal surface, record three times and take the average
Time Frame
The treatment period for each enrolled subject is one month
Title
SIt
Description
Fold one end of the special 5mm×35mm filter paper (Tianjin Jingming) for tears by 5mm, and gently place it on the middle and outer 1/3 of the subject's lower eyelid conjunctival sac, and the other end will droop naturally. Ask the subject to gently close their eyes for 5 minutes After measuring the length of the filter paper wetted by tears
Time Frame
The treatment period for each enrolled subject is one month
Title
CFS score
Description
Divide the cornea into 5 quadrants (central + nose/temporal/upper/lower), each quadrant has a staining score of 0 to 3 points, and it is specified that no staining is 0 points, and 30 spots are stained as 1 point, and there is flaky staining and fusion 3 points for filament formation, 2 points between the two, the sum of 5 quadrants is the score of the entire cornea, and the CFS score of the entire cornea is 0-15 points.
Time Frame
The treatment period for each enrolled subject is one month
Title
Density and curvature of corneal subbasal nerve
Description
Collect corneal subbasal nerve images, 2 images each in the upper, lower, arm, temporal and central areas. Use deep learning methods to analyze nerve density and curvature
Time Frame
The treatment period for each enrolled subject is one month
Title
Tear pain factor content
Description
With the aid of a slit lamp, a capillary pipette was used to draw 5 μl tears/eye at the middle and outer edges of the lower eyelid 2/3 of the tear river, and placed in a low protein adhesion EP tube (containing 5 μl 1% BSA) and stored at -80°C. ELISA analyzes the protein levels of PGE2, substance P and NGF in tear fluid.
Time Frame
The treatment period for each enrolled subject is one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive; VAS>0; Signed informed consent. Exclusion Criteria: Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days; Eyeball infections, allergies, deformities, abnormal movements Any history of eye surgery Have had eye trauma or fundus laser treatment within 3 months Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease

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