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Study on the Repeatability and Consistency of the Dr.eye Non-Contact Corneal Aesthesiometer

Study on the Repeatability and Consistency of the Dr.eye Non-Contact Corneal Aesthesiometer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123549
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurotrophic Keratitis

Interventions

NK group:NA

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Healthy group: (1) Age >=18 years, able to fully understand the study instructions and cooperate in completing all subjective examination items; (2) After fully understanding the purpose, methods, potential benefits and risks of this study, voluntarily participate in the study, and personally sign the written informed consent form, with good compliance and cooperation with follow-up visits. (3) Confirmed by slit-lamp microscope examination that both eyes have no active ocular surface disease, and no clinical evidence of corneal hypoesthesia. 2.Neurotrophic keratitis patient group: (1) Age >=18 years, able to fully understand the study instructions and cooperate in completing all subjective examination items; (2) After fully understanding the purpose, methods, potential benefits and risks of this study, voluntarily participate in the study, and personally sign the written informed consent form, with good compliance and cooperation with follow-up visits; (3) Based on medical history, signs and auxiliary examination results, clinically diagnosed as neurotrophic keratitis with reference to the "Chinese Expert Consensus on the Diagnosis and Treatment of Neurotrophic Keratitis (2021)"; all patients must be clearly diagnosed as "neurotrophic keratitis" by a specialist in the Corneal and Ocular Surface Disease Department of the Eye Hospital of Wenzhou Medical University in the outpatient clinic. (4) Able to tolerate the airflow stimulation and mechanical stimulation during the examination process, i.e., not in the acute phase, and no risk of corneal perforation. (5) If both eyes are affected, a randomization method will be used to determine which single eye is included in the study; if only one eye is affected, only the affected eye will be included in the study, and the contralateral healthy eye will not be included in the healthy group.

Exclusion criteria

Exclusion criteria: 1. Healthy Group: (1) Have systemic diseases that may cause peripheral neuropathy affecting corneal sensation, including but not limited to diabetes, Parkinson's disease, multiple sclerosis, autoimmune diseases, etc.; (2) History of eye surgery, including refractive surgery, history of trauma, history of corneal foreign bodies or chemical burns; (3) History of long-term or recent (within 3 months) contact lens wear; (4) Suffering from psychiatric disorders, cognitive dysfunction, or any other condition that prevents understanding study instructions and completing subjective examinations and follow-ups; (5) Pregnant or breastfeeding women, simultaneously participating in other interventional clinical studies, or any other factors judged by the researchers to be unsuitable for participating in this study. 2. Patients with Neurotrophic Keratitis: (1) Suffering from psychiatric disorders, cognitive dysfunction, or any other condition that prevents understanding study instructions and completing subjective examinations and follow-ups; (2) Pregnant or breastfeeding women, simultaneously participating in other interventional clinical studies, or any other factors judged by the researchers to be unsuitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Corneal sensation threshold measured by the Dr.eye non-contact corneal aesthesiometer;The longest nylon filament length at which the cornea perceives the stimulus, measured by the Cochet-Bonnet contact corneal aesthesiometer;

Countries

China

Contacts

Public ContactZelin Zhao

Eye Hospital, Wenzhou Medical University

zhaozelinwz@qq.com+86 135 8786 6512

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026