Retinal Nerve Fiber Layer Thickness Measurements in Patients With Sleep Apnea Syndrome

March 9, 2012 updated by: Orna Geyer, Carmel Medical Center

Retinal Nerve Fiber Layer Thickness Measurements Using Optical Coherence Tomography in Patients With Sleep Apnea Syndrome

The purpose of this study was to measure the retinal nerve fiber layer (RNFL) thickness in eyes of Obstructive Sleep Apnea/hypopnea syndrome (OSAHS) using optical coherence tomography (OCT), and assess whether it is decreased. The investigators then compared the results with healthy subjects database of RNFL thickness from another retrospective study.

Study Overview

Status

Completed

Conditions

Detailed Description

An association between glaucoma and OSAHS has been reported in several studies. Glaucoma is a progressive optic neuropathy involving loss of retinal ganglion cells and their axons at the level of the optic nerve head.Computerized technologies have now been successfully used in evaluating retinal nerve fiber layer (RNFL) thickness in glaucoma.Given the evidence of a possible link between OSAHS and glaucoma, it is reasonable that structural losses in retinal nerve fiber layer (RNFL) thickness would be present in OSAHS.Indeed,decreased retinal nerve fiber layers was found in patients with OSAHS, the severity of which correlated with the severity of the patients' OSAHS using scanning laser Polarimetry (SLP).Optical coherence tomography (OCT) provides quantitative RNFL thickness data by measuring the difference in the temporal delay of back-scattered light from the RNFL and a reference mirror.During the past decade, OCT has been used widely in clinical practice to discriminate glaucomatous eyes and eyes with early perimetric glaucoma from normal eyes. Several studies confirmed the accuracy and reproducibility of the RNFL thickness measurements by OCT. The thickness of the peripapillary RNFL was measured with the Stratus OCT(Carl Zeiss Meditec, Inc, Dublin,CA)using the fast scan protocol(3.4).Only good quality images, as judged by the well-focused and centered scans,no artifacts showing distorted anatomy, no missing parts and a signal strength ≥6, were used for further analysis. The considered OCT parameters were overall average RNFL thickness and the average RNFL thickness in 4 quadrants (superior, nasal,inferior,and temporal)extracted from the standard RNFL thickness analysis report(RNFL Thickness Average Analysis Protocol).

Study Type

Observational

Enrollment (Actual)

166

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

  • Israel
      • Haifa, Israel
        • Carmel Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome.

Description

Inclusion Criteria:

  • formal diagnosis of moderate or severe OSAHS
  • eligibility to sign informed consent form
  • older than 18 years

Exclusion Criteria:

  • known glaucoma
  • not eligible to sign informed consent form
  • younger than 18 years
  • incompetent persons who lack decision making capability

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

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Sleep Apnea / Hypopnea syndrome
Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers.
Time Frame: four months
four months

Collaborators and Investigators

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

Sponsor

Carmel Medical Center

Investigators

  • Principal Investigator: Orna Geyer, Prof, Carmel Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 24, 2010

First Posted (Estimate)

August 25, 2010

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 9, 2012

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC070029CTIL

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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