IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure

Sensimed

Status

Completed

Conditions

Sleep Apnea, Obstructive

Primary Open-angle Glaucoma

Treatments

Device: SENSIMED Triggerfish®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01560975

TF-1108

Details and patient eligibility

About

Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common sleep-related breathing disorder and is characterized by repeated partial or complete upper airway collapse, gasping episodes, daytime sleepiness and fatigue. Once suspected, the diagnosis is made on the basis of anamnesis and a polysomnography (PSG) using the so-called respiratory disturbance index (RDI) to grade OSAS. Standard therapy consists of continuous positive airway pressure (CPAP) during sleep to prevent upper airway collapse. The association between OSAS and glaucoma has been extensively studied, although a few reports have been non-confirmatory. OSAS has been associated with reduced ocular blood flow, leading to hypoxia and hypercapnia, and as such, may represent a risk factor for glaucomatous optic neuropathy. OSAS has also been related to loss of nycthemeral rhythm of intraocular pressure (IOP). In addition, CPAP has been reported to increase IOP when used during nighttime.

The purpose of this study is to investigate how IOP varies in time, particularly during sleep in OSAS patients with or without glaucoma, and if the IOP variations are associated with the use of CPAP. IOP fluctuations will be monitored with SENSIMED Triggerfish®, a portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.

Enrollment

10 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a confirmed diagnosis of moderate to severe OSAS, determined by a RDI > 15 on PSG
Patient has either POAG with controlled IOP or no glaucoma. Five of each will included in the study
Patients under CPAP therapy
Aged ≥ 18 years, of either sex
Not more than 4 diopters spherical equivalent on the study eye
Not more than 2 diopters cylinder equivalent on the study eye
Have given written informed consent, prior to any investigational procedures

Exclusion criteria

Sleep disorders other than OSAS
Use of sleep medication
Patients with history of intraocular surgery (including laser therapy) within the last 3 months
Corneal or conjunctival abnormality hindering contact lens adaptation
Severe dry eye syndrome
Patients with allergy to corneal anesthetic
Patients with contraindications for silicone contact lens wear
Patients not able to understand the character and individual consequences of the investigation
Participation in other clinical research within the last 30 days