Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2019
Effects of botulinum toxin type A on the treatment of dry eye disease and tear cytokines.
Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Botulinum toxin effects on biochemical biomarkers related to inflammation-associated head and neck chronic conditions: a systematic review of clinical research.Journal of neural transmission (Vienna, Austria : 1996) · 2025Pooled it
- Is Botulinum toxin A effective in treating dry eye disease? A systematic review and meta-analysis.Eye (London, England) · 2025Pooled it
- TFOS Lifestyle: Impact of cosmetics on the ocular surface.The ocular surface · 2023Pooled it
- Placebo administration for dry eye disease: a level I evidence based systematic review and meta-analysis.International journal of clinical pharmacy · 2022Pooled it
- Effects of periocular botulinum toxin injection on ocular surface parameters and pupillary dynamics: a prospective clinical study.International ophthalmology · 2026Article
- Is Current Evidence Sufficient to Establish the Efficacy of Botulinum Toxin A in Treating Persistent Dry Eye Disease? A Systematic Review and Meta-Analysis of Interventional Studies With a Critical Review Using GRADE Tool.Health science reports · 2026Review
- Dry Eye Disease: From Mechanisms to Management and Future Directions.Journal of clinical medicine · 2026Review
- Epidemiology and Risk Factors of Dry Eye Disease: Considerations for Clinical Management.Medicina (Kaunas, Lithuania) · 2024Review
- Impact of dry eye disease treatment on patient quality of life.Frontiers in medicine · 2024Review
- Tear biomarkers in dry eye disease: Progress in the last decade.Indian journal of ophthalmology · 2023Review
- Botulinum Neurotoxin Type a Injection Combined with Absorbable Punctal Plug Insertion: An Effective Therapy for Blepharospasm Patients with Dry Eye.Journal of clinical medicine · 2023Article
- Botulinum Toxin A Injection for the Treatment of Intractable Dry Eye Disease.Medicina (Kaunas, Lithuania) · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo determine the effects of botulinum toxin type A (BTX-A) injection on dry eye signs, symptoms, and tear cytokine levels in patients with intractable dry eye disease (DED).
methodsIn this prospective study, patients with intractable DED were randomized to a BTX-A (group A) or control group (group B). Patients were injected with BTX-A or normal saline in the medial part of the upper and lower eyelids. Before and at 2 weeks, 1 month, 2 months, and 4 months after injection, dry eye signs; tear film break-up time (TBUT), Schirmer I test, corneal fluorescein staining (CFS), and symptoms; ocular surface disease index (OSDI); and frequency of lubricants were assessed. The tear levels of matrix metalloproteinase (MMP)-9 and serotonin were measured before and at 1 month after injection.
resultsFifty-two eyes from 26 patients (mean age, 57.7 years) were included. The TBUT was higher at 2 weeks and at 1 month in group A. The Schirmer I test and OSDI scores were also better in group A for up to 2 months. The CFS grades in group A were significantly lower until 4 months. Repeated measures analysis of variance (RMANOVA) demonstrated significant differences between the two groups over time for the Schirmer I test (p = 0.002), CFS (p = 0.025), OSDI (p = 0.020), and frequency of lubricants (p = 0.029). The MMP-9 conversion rate of group A (76.92%) was significantly higher than that of group B (38.46%, p = 0.005). The tear serotonin level in group A was reduced from 2.76 ± 0.34 to 1.73 ± 0.14 ng/mL (p < 0.001). No complications were observed during the study.
conclusionBTX-A injection into the medial part of eyelid improves dry eye signs and symptoms and reduces tear cytokine levels. BTX-A is thus a potential treatment option for patients with intractable DED.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.