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Clinical Trials/NCT01188291
NCT01188291
Completed
Not Applicable

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

Carmel Medical Center1 site in 1 country166 target enrollmentSeptember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Carmel Medical Center
Enrollment
166
Locations
1
Primary Endpoint
Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers.
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

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).

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
January 2009
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Carmel Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Orna Geyer

Professor

Carmel Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers.

Time Frame: four months

Study Sites (1)

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