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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06287879
Other study ID # 20231121
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date December 30, 2024

Study information

Verified date November 2023
Source Zhongnan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592). Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms. This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia


Description:

1. Collect medical records of patients with renal anemia who visited the ophthalmology outpatient department of Zhongnan Hospital and hospitalized patients with renal anemia 2. Patients were divided into Rosallistat group, and EPO group according to their drug use history. 3. The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of dry eye examination were analyzed statistically. 4. Complete data collection, conduct statistical analysis, and evaluate the analysis results.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2024
Est. primary completion date December 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - long-term use of Roxadustat or erythropoietin for renal anemia Exclusion Criteria: - contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations

Study Design


Intervention

Diagnostic Test:
Dry eye examination
Lacrimal river height tear break-up time tear-film lipid layer thickness meibomian glands two-dimensional digital infrared images

Locations

Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lacrimal river height Measured by dry eye analyzer machine Immediately and six months later
Primary tear break-up time Measured by dry eye analyzer machine Immediately and six months later
Primary tear-film lipid layer thickness Measured by dry eye analyzer machine Immediately and six months later
Primary meibomian glands two-dimensional digital infrared images Measured by dry eye analyzer Immediately and six months later
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