NCT02405884

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Last Updated

April 3, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

March 24, 2015

Last Update Submit

March 31, 2015

Conditions

Keywords

GlaucomaRenal Insufficiency, ChronicLow Tension GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

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

    baseline (before hemodialysis ) and end of hemodialysis ( four hours late)

Study Arms (1)

measurement of intraocular pressure

OTHER

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.

Other: Kowa HA-2 Perkins applanation tonometer.

Interventions

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.

measurement of intraocular pressure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 24232671BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, ChronicGlaucomaLow Tension GlaucomaOcular Hypertension

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsEye DiseasesOptic Nerve Diseases

Study Officials

  • Francisco W Rodrigues, Professor

    PUC Goias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ophthalmologist

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 1, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

April 3, 2015

Record last verified: 2015-03