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Observational Study of Corneal Nerves in Corneal and Conjunctival Diseases

Comprehensive Observational Study of Corneal Nerve Structure and Function in Corneal and Conjunctival Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1052260085
Enrollment
400
Registered
2026-06-17
Start date
2026-05-27
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

corneal or conjunctival diseases, including dry eye disease, severe ocular surface diseases, keratoc corneal nerves, cornea, conjunctiva, ocular surface diseases

Interventions

The examinations performed in this study will generally remain within the scope of routine ophthalmic clinical practice. However, corneal sensitivity testing using the Brill non-contact corneal esthes
D003941
non contact corneal esthesiometer, Brill, corneal sensitivity testing, corneal sensitivity, Cochet Bonnet esthesiometer

Sponsors

Sotozono Chie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients visiting the study institutions who have been diagnosed with corneal or conjunctival diseases, including dry eye disease, severe ocular surface diseases, keratoconus, postoperative status after cataract surgery, postoperative status after refractive surgery such as LASIK, and other conditions suspected to involve corneal nerve impairment.

Exclusion criteria

Exclusion criteria: Patients who are unable to provide written informed consent of their own free will after receiving a sufficient explanation of the study. Patients who are younger than 18 years of age at the time of obtaining consent. Patients whose capacity to provide informed consent cannot be confirmed. Patients in whom corneal sensitivity measurement, anterior segment imaging, or other examinations planned in this study are judged to be difficult to perform safely or appropriately. Patients who are judged by the principal investigator or sub-investigators to be unsuitable for participation in the study for any other reason.

Design outcomes

Primary

MeasureTime frame
Association between corneal nerve fiber distribution, as qualitatively and quantitatively assessed using in vivo confocal microscopy (HRT) and contact specular microscopy, and corneal sensitivity thresholds measured using the Cochet Bonnet esthesiometer or the Brill non-contact corneal esthesiometer.

Secondary

MeasureTime frame
Secondary endpoints include disease-specific changes in corneal nerve fiber distribution and corneal sensitivity thresholds; associations between nerve structural and functional parameters and subjective symptom scores such as OPAS-J, DEQS, and OSDI; perioperative changes in corneal nerve fiber distribution and corneal sensitivity thresholds; associations between nerve regeneration parameters and ocular surface findings, postoperative pain scores, and other clinical findings; associations between nerve parameters and OSGS, NEI corneal and conjunctival staining scores, and dry eye severity; and associations between nerve parameters and visual function or other ophthalmic findings.

Contacts

Public ContactSeitaro Komai

Kyoto Prefectural University of Medicine

s-koma@koto.kpu-m.ac.jp+81-75-251-5578

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026