ClinicalTrials.gov
ClinicalTrials.gov Menu

Serum Bilirubin Levels in Normal-tension Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03387306
Recruitment Status : Completed
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sadık Altan Ozal, Trakya University

Brief Summary:

Purpose: To analyze the relationship between normal-tension glaucoma (NTG) and serum bilirubin levels.

Materials and Methods: This research included 38 patients with NTG and 38 healthy controls with similar age and sex distribution, for a total of 76 subjects. Serum samples were taken from all of the subjects, direct serum bilirubin, indirect serum bilirubin and the total serum bilirubin were measured.


Condition or disease
Normal Tension Glaucoma Bilirubin; Defect, Excretion

Detailed Description:

This is a retrospective study of cases with recently or previously diagnosed NTG who were admitted to our clinic between 2010 and 2017. This study included 38 patients with NTG and 38 healthy controls with similar age and sex distribution, for a total of 76 subjects. Written informed consent was obtained from all of the participants. The study was approved by the institutional review board of the hospital and adhered to the tenets of the Declaration of Helsinki.

A complete ophthalmic examination including best-corrected visual acuity, slit-lamp biomicroscopy, Goldmann applanation tonometry (AT 900, Haag-Streit Diagnostics, Koeniz, CH), corneal thickness evaluation (Pachymeter SP-3000, Tomey Corporation, Nagoya, JP), gonioscopy and ophthalmoscopy was performed in all NTG cases. Additionally, optical coherence tomography (OCT RS-3000 Lite, NIDEK Corporation, Tokyo, JP) measurement of the peripapillary retinal nerve fibre layer thickness, and Humprey visual field testing (Carl-Zeiss Meditec, Dublin, CA) were also performed.

NTG was diagnosed based on a clinical examination showing a normal IOP (corrected for corneal thickness), thinning of the peripapillary retinal nerve fibre layer, optic nerve damage, and characteristic glaucomatous visual field defects. The exclusion criteria included other forms of glaucoma such as primary open-angle glaucoma, primary closed-angle glaucoma, pigmentary glaucoma and exfoliative glaucoma. Patients who had active systemic diseases such as those affecting the liver, biliary system, pancreas and kidney and infectious diseases or malignant tumours that could influence the serum bilirubin concentrations were also excluded.

Fasting blood samples were taken from each participant to measure direct bilirubin, indirect bilirubin, and the total serum bilirubin concentrations. The direct bilirubin and total bilirubin concentrations were measured with an Architect C16000 Clinical Chemistry Analyzer (Abbott Laboratories, Abbott Park, IL, USA), using its original kits, and the indirect bilirubin concentrations were calculated by the following formula: indirect bilirubin = total bilirubin - direct bilirubin.

All the data were compiled into a computer file, and Statistical Package for Social Sciences for Windows 22.0 was used to perform the statistical analysis. Student's t test or the Mann-Whitney U test were used to compare the mean values between the two groups, after the evaluation of the data for a normal distribution using the Kolmogorov-Smirnov test. A p value less than 0.05 was considered statistically significant.


Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Reduced Serum Bilirubin Levels in Patients With Normal-tension Glaucoma
Actual Study Start Date : January 2010
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
Patient group
This grup included 38 patients with NTG.
Control group
This group included 38 healthy controls.



Primary Outcome Measures :
  1. Serum Bilirubin Levels [ Time Frame: January 2017-March 2017 ]
    Serum indirect, direct and total bilirubin levels



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
NTG was diagnosed based on a clinical examination showing a normal IOP (corrected for corneal thickness), thinning of the peripapillary retinal nerve fibre layer, optic nerve damage, and characteristic glaucomatous visual field defects. The exclusion criteria included other forms of glaucoma such as primary open-angle glaucoma, primary closed-angle glaucoma, pigmentary glaucoma and exfoliative glaucoma. Patients who had active systemic diseases such as those affecting the liver, biliary system, pancreas and kidney and infectious diseases or malignant tumours that could influence the serum bilirubin concentrations were also excluded.
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Patients who had active systemic diseases such as those affecting the liver, biliary system, pancreas and kidney and infectious diseases or malignant tumours that could influence the serum bilirubin concentrations were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387306


Locations
Turkey
Sadık Altan Ozal
Edirne, In The USA Or Canada, Please Select..., Turkey, 22030
Sponsors and Collaborators
Trakya University
Investigators
Principal Investigator: Sadık Altan Ozal Trakya University

Publications of Results:

Responsible Party: Sadık Altan Ozal, Assistant of Proffessor, Trakya University
ClinicalTrials.gov Identifier: NCT03387306     History of Changes
Other Study ID Numbers: 14783786
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sadık Altan Ozal, Trakya University:
serum bilirubin
normal-tension glaucoma
oxidative stress

Additional relevant MeSH terms:
Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs