Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia

February 27, 2024 updated by: Zhongnan Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Roxadustat
Subjects were treated with Roxadustat for renal anemia
Diagnostic test: Dry eye examination
  1. Lacrimal river height
  2. tear break-up time
  3. tear-film lipid layer thickness
  4. meibomian glands two-dimensional digital infrared images
Active Comparator: EPO
Subjects were treated with EPO for renal anemia
Diagnostic test: Dry eye examination
  1. Lacrimal river height
  2. tear break-up time
  3. tear-film lipid layer thickness
  4. meibomian glands two-dimensional digital infrared images

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongnan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20231121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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