Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01188291
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : March 12, 2012
Sponsor:
Information provided by (Responsible Party):
Orna Geyer, Carmel Medical Center

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.

Condition or disease
Obstructive Sleep Apnea Hypopnea Syndrome Glaucoma

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Retinal Nerve Fiber Layer Thickness Measurements Using Optical Coherence Tomography in Patients With Sleep Apnea Syndrome
Study Start Date : September 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Retinal Nerve Fiber Layer Thickness as measured Optical Coherence Tomography, and expressed in micrometers. [ Time Frame: four months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study group composed of patients with Obstructive Sleep Apnea / Hypopnea syndrome.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188291


Locations
Layout table for location information
Israel
Carmel Medical Center
Haifa, Israel
Sponsors and Collaborators
Carmel Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Orna Geyer, Prof Carmel Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Orna Geyer, Professor, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01188291    
Other Study ID Numbers: CMC070029CTIL
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: March 12, 2012
Last Verified: August 2010
Keywords provided by Orna Geyer, Carmel Medical Center:
Optical Coherence Tomography
Retinal Nerve Fiber Layer Thickness
Obstructive Sleep Apnea
Hypopnea syndrome
Glaucoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Glaucoma
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Ocular Hypertension
Eye Diseases