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Intraocular Pressure and Hemodialysis Midwestern Brazil (EHPIOBRAZIL)

Primary Purpose

Renal Insufficiency, Chronic, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kowa HA-2 Perkins applanation tonometer.
Sponsored by
VER Excelência em Oftalmologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Insufficiency, Chronic focused on measuring Glaucoma, Renal Insufficiency, Chronic, Low Tension Glaucoma, Ocular Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic renal patients
  • Patientes signed the informed consent form and were able to undergo a physical examination
  • Patients between 18-75 years of age

Exclusion Criteria:

  • Patients with chronic eye disease and / or eye surgery
  • Patients allergic to anesthetic drops or dyes.
  • Patients who had no physical condition to the eye examination
  • Patients who refused to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    measurement of intraocular pressure

    Arm Description

    Patients were divided into groups according to the days on which they underwent hemodialysis. Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops.

    Outcomes

    Primary Outcome Measures

    assess changes in intraocular pressure (mmHg) before and after hemodialysis

    Secondary Outcome Measures

    Full Information

    First Posted
    March 24, 2015
    Last Updated
    March 31, 2015
    Sponsor
    VER Excelência em Oftalmologia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02405884
    Brief Title
    Intraocular Pressure and Hemodialysis Midwestern Brazil
    Acronym
    EHPIOBRAZIL
    Official Title
    Effects of Hemodialysis on Intraocular Pressure in a University Hospital Located in Midwestern Brazil
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    VER Excelência em Oftalmologia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: To evaluate the variation in intraocular pressure in patients with chronic kidney disease, according to the time interval between hemodialysis sessions and to the influence of weight and blood pressure on intraocular pressure. Methods: This was a cross-sectional study in which 78 eyes of 39 patients on hemodialysis, at the Santa Casa de Misericordia de Goiânia hospital, were analyzed in June 2014. Patients were divided into groups according to the days on which they underwent hemodialysis. The mean, standard deviation, and median of the intraocular pressure, blood pressure, and weight were calculated. P-values <0.05 were considered statistically significant.
    Detailed Description
    This cross-sectional observational study followed the guidelines of the Declaration of Helsinki, and all patients signed an informed consent form approved by the Ethics and Research Committee of the Pontifical Catholic University of Goiás (Pontifícia Universidade Católica de Goiás - PUC-GO). The inclusion criteria were chronic renal patients, who were older than 18 years of age, were part of the hemodialysis program of the Santa Casa de Misericordia de Goiânia (SCMG) hospital, signed the informed consent form and were able to undergo a physical examination. Exclusion criteria were patients on hemodialysis who were not chronic renal patients; patients who refused to participate in the study or could not undergo a physical examination; patients who did not undergo hemodialysis in the week of the study; prior ophthalmic eye disease or surgery; and patients allergic to anesthetic drops or dyes. Patients were divided into groups according to the days on which they underwent hemodialysis. A total of 39 patients who were on hemodialysis at SCMG for six days in the month of June 2014 were analyzed. The patient's eye fundus was evaluated through direct ophthalmoscopy with a PanOptic device (Welch Allyn). Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops. The variables studied were age, gender, base etiology for CKD, and variations in body weight and IOP before and after hemodialysis. Mean blood pressure (MBP), systolic blood pressure (SBP), diastolic blood pressure (DBP), and ocular perfusion pressure (OPP) were obtained before and after hemodialysis. The following mathematical models were used: MBP = (DBP) + 1/3 (SBP) - (DBP) and OPP = 2/3 (MBP-IOP), as described in the literature (18-20). The data were collected using a form devised for the study from the medical records of the chronic renal patients undergoing hemodialysis at SCMG and registered in the system. The data were tabulated in a Microsoft© Excel 2007 spreadsheet and analyzed using the Statistical Package for the Social Sciences, version 20 (SPSS, Chicago, IL). The mean, standard deviation, median IOP measurements, blood pressure, and weight were obtained. Data normality was assessed by the Kolmogorov-Smirnov test. The significance of differences between measurements obtained before and after hemodialysis was assessed by the Wilcoxon test. The relationship between IOP and weight was assessed by Pearson's or Spearman's correlation. P-values <0.05 were considered significant.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency, Chronic, Glaucoma
    Keywords
    Glaucoma, Renal Insufficiency, Chronic, Low Tension Glaucoma, Ocular Hypertension

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    measurement of intraocular pressure
    Arm Type
    Other
    Arm Description
    Patients were divided into groups according to the days on which they underwent hemodialysis. Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops.
    Intervention Type
    Other
    Intervention Name(s)
    Kowa HA-2 Perkins applanation tonometer.
    Intervention Description
    Patients were divided into groups according to the days on which they underwent hemodialysis. Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops.
    Primary Outcome Measure Information:
    Title
    assess changes in intraocular pressure (mmHg) before and after hemodialysis
    Time Frame
    baseline (before hemodialysis ) and end of hemodialysis ( four hours late)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic renal patients Patientes signed the informed consent form and were able to undergo a physical examination Patients between 18-75 years of age Exclusion Criteria: Patients with chronic eye disease and / or eye surgery Patients allergic to anesthetic drops or dyes. Patients who had no physical condition to the eye examination Patients who refused to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francisco W Rodrigues, Professor
    Organizational Affiliation
    PUC Goias
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24232671
    Citation
    Hu J, Bui KM, Patel KH, Kim H, Arruda JA, Wilensky JT, Vajaranant TS. Effect of hemodialysis on intraocular pressure and ocular perfusion pressure. JAMA Ophthalmol. 2013 Dec;131(12):1525-31. doi: 10.1001/jamaophthalmol.2013.5599.
    Results Reference
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