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

NCT ID: NCT01188291

Last Updated: 2012-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-01-31

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).

Conditions

Obstructive Sleep Apnea; Hypopnea Syndrome; Glaucoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sleep Apnea / Hypopnea syndrome

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Orna Geyer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orna Geyer, Prof

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Countries

Israel

References

Sagiv O, Fishelson-Arev T, Buckman G, Mathalone N, Wolfson J, Segev E, Peled R, Lavi I, Geyer O. Retinal nerve fibre layer thickness measurements by optical coherence tomography in patients with sleep apnoea syndrome. Clin Exp Ophthalmol. 2014 Mar;42(2):132-8. doi: 10.1111/ceo.12145. Epub 2013 Jul 15.

Reference Type: DERIVED

PMID: 23777553 (View on PubMed)

Other Identifiers

CMC070029CTIL

Identifier Type: -

Identifier Source: org_study_id