Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2024-01-15
2025-08-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Artificial Tears Only
Participants received topical artificial tears (sodium hyaluronate/CMC-based eye drops) according to standard treatment protocol. No additional intervention was given.
Artificial tears
Topical artificial tears were administered as standard therapy for moderate dry eye disease.
Experimental: Artificial Tears + Acupuncture
Participants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes.
Artificial tears
Topical artificial tears were administered as standard therapy for moderate dry eye disease.
Traditional Chinese Medicine Acupuncture
Acupuncture therapy performed by a certified specialist using sterile disposable needles at predefined local and systemic acupoints (BL2, ST1, GB1, SJ23, Ex-HN5, LI4, ST36, SP6, LIV3, GB37, GB40, Ex-HN3, Du23, BL64). Sessions were delivered twice weekly for a total of 10 sessions, each lasting 20 minutes. Deqi sensation was obtained by manual stimulation. No additional systemic or topical treatments were provided to participants in this arm.
Interventions
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Artificial tears
Topical artificial tears were administered as standard therapy for moderate dry eye disease.
Traditional Chinese Medicine Acupuncture
Acupuncture therapy performed by a certified specialist using sterile disposable needles at predefined local and systemic acupoints (BL2, ST1, GB1, SJ23, Ex-HN5, LI4, ST36, SP6, LIV3, GB37, GB40, Ex-HN3, Du23, BL64). Sessions were delivered twice weekly for a total of 10 sessions, each lasting 20 minutes. Deqi sensation was obtained by manual stimulation. No additional systemic or topical treatments were provided to participants in this arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Nadide Koca
OTHER
Responsible Party
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Nadide Koca
Principal Investigator, M.D., Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
Principal Investigators
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Nadide Koca
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital
Locations
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Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230
Ankara, Altindag, Turkey (Türkiye)
Countries
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References
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Duan H, Zhou Y, Ma B, Liu R, Yang T, Chu H, Huo Z, Qi H. Effect of Acupuncture Treatment on the Ocular Pain, Mental State and Ocular Surface Characteristics of Patients with Dry Eye Disease: A Non-Randomized Pilot Study. Clin Ophthalmol. 2024 Oct 3;18:2751-2764. doi: 10.2147/OPTH.S476573. eCollection 2024.
Zhang X, Zhang B, Peng S, Zhang G, Ma J, Zhu W. Effectiveness of acupuncture at acupoint BL1 (Jingming) in comparison with artificial tears for moderate to severe dry eye disease: a randomized controlled trial. Trials. 2022 Jul 27;23(1):605. doi: 10.1186/s13063-022-06486-4.
Wang Y, Peng J, Xiao L, Deng Y, Lu J, Zhou YS, Yang YJ, Peng QH. Effectiveness of acupuncture combined with artificial tears in managing dry eye syndrome: A systematic review and meta-analysis. Medicine (Baltimore). 2024 Jan 5;103(1):e36374. doi: 10.1097/MD.0000000000036374.
Moon SY, Chung HS, Lee JH, Lee H, Tchah H, Kim JY. Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation. BMC Ophthalmol. 2024 Sep 9;24(1):401. doi: 10.1186/s12886-024-03620-5.
Bawazeer AM, Hodge WG. One-minute schirmer test with anesthesia. Cornea. 2003 May;22(4):285-7. doi: 10.1097/00003226-200305000-00001.
Kuang H, Zhu X, Chen H, Tang H, Zhao H. The immunomodulatory mechanism of acupuncture treatment for ischemic stroke: research progress, prospects, and future direction. Front Immunol. 2024 May 2;15:1319863. doi: 10.3389/fimmu.2024.1319863. eCollection 2024.
Oh JE, Kim SN. Anti-Inflammatory Effects of Acupuncture at ST36 Point: A Literature Review in Animal Studies. Front Immunol. 2022 Jan 12;12:813748. doi: 10.3389/fimmu.2021.813748. eCollection 2021.
McCann P, Kruoch Z, Lopez S, Malli S, Qureshi R, Li T. Interventions for Dry Eye: An Overview of Systematic Reviews. JAMA Ophthalmol. 2024 Jan 1;142(1):58-74. doi: 10.1001/jamaophthalmol.2023.5751.
McMonnies CW. Why the symptoms and objective signs of dry eye disease may not correlate. J Optom. 2021 Jan-Mar;14(1):3-10. doi: 10.1016/j.optom.2020.10.002. Epub 2020 Nov 23.
Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.
Cartes C, Aravena C, Monsalve A, Segovia C, Romero C, Quidel D, Cid F, Monsalve R, Navarro L, Araya D, Araneda D, Sepulveda M. Prevalence of Dry Eye Disease in Laser-Assisted In Situ Keratomileusis Candidates. Eye Contact Lens. 2024 Jul 1;50(7):305-310. doi: 10.1097/ICL.0000000000001095. Epub 2024 May 2.
Chen A, Augello P, Asbell P, Ying GS; DREAM Research Group. The repeatability of tests for dry eye signs and symptoms in the dry eye assessment and management (DREAM) study. Cont Lens Anterior Eye. 2025 Apr;48(2):102322. doi: 10.1016/j.clae.2024.102322. Epub 2024 Oct 30.
Qian L, Wei W. Identified risk factors for dry eye syndrome: A systematic review and meta-analysis. PLoS One. 2022 Aug 19;17(8):e0271267. doi: 10.1371/journal.pone.0271267. eCollection 2022.
Kwon J, Moghtader A, Kang C, Bibak Bejandi Z, Shahjahan S, Alzein A, Djalilian AR. Overview of Dry Eye Disease for Primary Care Physicians. Medicina (Kaunas). 2025 Mar 6;61(3):460. doi: 10.3390/medicina61030460.
Mathebula SD, Khosa PR, Maleswene MM. Comparison of patient reported dry eye symptoms as evaluated by the ocular surface disease index and symptom assessment. Afr J Prim Health Care Fam Med. 2025 May 21;17(1):e1-e7. doi: 10.4102/phcfm.v17i1.4861.
Bhatt K, Singh S, Singh K, Kumar S, Dwivedi K. Prevalence of dry eye, its categorization (Dry Eye Workshop II), and pathological correlation: A tertiary care study. Indian J Ophthalmol. 2023 Apr;71(4):1454-1458. doi: 10.4103/IJO.IJO_2591_22.
Britten-Jones AC, Wang MTM, Samuels I, Jennings C, Stapleton F, Craig JP. Epidemiology and Risk Factors of Dry Eye Disease: Considerations for Clinical Management. Medicina (Kaunas). 2024 Sep 5;60(9):1458. doi: 10.3390/medicina60091458.
Bhujbal S, Rupenthal ID, Steven P, Agarwal P. Inflammation in Dry Eye Disease-Pathogenesis, Preclinical Animal Models, and Treatments. J Ocul Pharmacol Ther. 2024 Dec;40(10):638-658. doi: 10.1089/jop.2024.0103. Epub 2024 Oct 2.
Sheppard J, Shen Lee B, Periman LM. Dry eye disease: identification and therapeutic strategies for primary care clinicians and clinical specialists. Ann Med. 2023 Dec;55(1):241-252. doi: 10.1080/07853890.2022.2157477.
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
Other Identifiers
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2023/11-090224
Identifier Type: OTHER
Identifier Source: secondary_id
AnkaraTRH-FTR-NK-09
Identifier Type: -
Identifier Source: org_study_id
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