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Serum Bilirubin Levels in Normal-tension Glaucoma

Sponsor
Trakya University (Other)
Overall Status
Completed
CT.gov ID
NCT03387306
Collaborator
(none)
76
Enrollment
1
Location
87
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 1, 2010
    Actual Primary Completion Date :
    Mar 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Patient group

    This grup included 38 patients with NTG.
    Control group

    This group included 38 healthy controls.

    Outcome Measures

    Primary Outcome Measures

    1. Serum Bilirubin Levels [January 2017-March 2017]

      Serum indirect, direct and total bilirubin levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sadık Altan Ozal, Assistant of Proffessor, Trakya University
    ClinicalTrials.gov Identifier:
    NCT03387306
    Other Study ID Numbers:
    • 14783786
    First Posted:
    Jan 2, 2018
    Last Update Posted:
    Jan 2, 2018
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Assistant of Proffessor, Trakya University
    serum bilirubin
    normal-tension glaucoma
    oxidative stress
    Additional relevant MeSH terms:
    Glaucoma
    Low Tension Glaucoma

    Study Results

    No Results Posted as of Jan 2, 2018