Medical vs Acupuncture for Dry Eye (ADET)

Nadide Koca

Status: Completed

Conditions: Dry Eye; Acupuncture

Treatments: Drug: Artificial tears; Other: Traditional Chinese Medicine Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT07185854

2023/11-090224 (Other Identifier)

AnkaraTRH-FTR-NK-09

Details and patient eligibility

About

This randomized clinical trial was designed to evaluate the effectiveness of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate dry eye disease. A total of 90 participants were enrolled at the University of Health Sciences, Ankara Training and Research Hospital. Patients were randomly assigned to receive either artificial tears only or artificial tears with acupuncture. Acupuncture was performed twice weekly for ten sessions by a certified specialist.

Assessments were conducted at baseline, after treatment, and at one-month follow-up using the Ocular Surface Disease Index (OSDI), Schirmer test, and tear break-up time (tBUT). The primary outcome measure was the change in OSDI score, while secondary outcomes included Schirmer test values and tBUT.

Full description

Dry eye disease (DED) is a chronic ocular surface disorder characterized by instability of the tear film, ocular discomfort, and visual disturbance. It significantly impairs quality of life, limiting daily activities such as reading, driving, and computer use. Standard treatments, including artificial tears and anti-inflammatory agents, often provide only partial or temporary relief and may not adequately address the underlying inflammatory mechanisms. As a complementary approach, acupuncture has been suggested to improve lacrimal gland function, enhance tear secretion, and reduce ocular inflammation, yet comparative evidence in moderate DED remains limited.

The aim of this study was to evaluate the short-term efficacy of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate DED. This prospective, randomized, controlled, parallel-group trial was conducted at the University of Health Sciences, Ankara Training and Research Hospital. Ninety adults aged 18-65 years, diagnosed with moderate DED according to TFOS DEWS II criteria (Schirmer 5-10 mm and tear break-up time 6-10 seconds), were enrolled between January 2024 and May 2025. Participants were randomly allocated to two groups: Group 1 received artificial tears only, while Group 2 received artificial tears plus acupuncture.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 65 years
• Diagnosis of moderate dry eye disease according to TFOS DEWS II criteria
• Anesthetized Schirmer test result between 5-10 mm
• Tear break-up time (tBUT) between 6-10 seconds
• Ocular Surface Disease Index (OSDI) score ≥ 13
• Symptom duration of at least 3 months
• Signed informed consent form

Exclusion criteria

• Sjögren's syndrome, active blepharitis, or meibomian gland dysfunction
• Systemic rheumatologic, autoimmune, or metabolic disease (e.g., diabetes)
• Use of systemic or topical treatment for dry eye within the last 6 months
• Previous ocular surgery
• Contact lens use
• Pregnancy or lactation
• History of neurological or psychiatric disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Artificial Tears Only

Active Comparator group

Description:

Participants received topical artificial tears (sodium hyaluronate/CMC-based eye drops) according to standard treatment protocol. No additional intervention was given.

Treatment:

Drug: Artificial tears

Experimental: Artificial Tears + Acupuncture

Experimental group

Description:

Participants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes.

Treatment:

Other: Traditional Chinese Medicine Acupuncture

Drug: Artificial tears