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Completed

NCT Number: NCT04668131

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium hyaluronate eye drops

Drug

eye drops, three times a day

Other names: artificial tears

Acupuncture

Other

three times a week

Primary outcomes

  1. Visual Analogue Score

    Time frame: The treatment period for each enrolled subject is one month

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

Secondary outcomes

  1. OSDI

    Time frame: The treatment period for each enrolled subject is one month

    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.

  2. TBUT

    Time frame: The treatment period for each enrolled subject is one month

    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

  3. SIt

    Time frame: The treatment period for each enrolled subject is one month

    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

  4. CFS score

    Time frame: The treatment period for each enrolled subject is one month

    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.

  5. Density and curvature of corneal subbasal nerve

    Time frame: The treatment period for each enrolled subject is one month

    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

  6. Tear pain factor content

    Time frame: The treatment period for each enrolled subject is one month

    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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2020
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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