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Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness

ConditionsNormal Tension GlaucomaObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorNorthwell Health

About this trial

The purpose of this research study is to learn more about the relationship between Obstructive Sleep Apnea (OSA) and Normal Tension Glaucoma (NTG). OSA is a nighttime disorder of the upper airway that causes an intermittent lack of oxygen while sleeping. NTG is a type of glaucoma that occurs despite the normal intraocular pressure levels, making its detection more difficult. Left untreated, irreversible optic nerve damage and extensive vision loss can result. Previous research has shown some evidence between OSA and the development of NTG. The investigators are researching whether undergoing treatment for OSA would help to improve the vascular health to the retina, and in effect, improve the early signs of visual dysfunction seen with diagnostic testing.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed subjects with OSA that will undergo CPAP treatment.

At least 21 years of age

Best corrected vision of 20/40 or better, spherical Rx < ± 6.0 Diopter, and cylinder <-3.0D

Ability to follow instructions, and intent to complete all study visits

Disqualifiers

High Rx >± 6.0D and cylinder > -3.0D

Narrow angle glaucoma

History of any of the following: severe eye trauma, ocular inflammation, previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation.

Any medical or ocular condition which is not appropriate for participation in the trial (Diabetic retinopathy, and other retinal changes preventing reliable optic disc evaluation) Hypersensitivity to any component of altafluor benox

Trial population

Newly-diagnosed OSA patients that will undergo CPAP treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Clinical observation, diagnostic testing

    Other intervention

    Glaucoma evaluation including structural and functional diagnostic testing at baseline and 3 subsequent follow-up visits over a period of 9 months

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Newly-diagnosed mild OSA - initiating CPAP treatment1 intervention
Group B: Newly-diagnosed moderate OSA - initiating CPAP treatment1 intervention
Group C: Newly-diagnosed severe OSA - initiating CPAP treatment1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of NTG

To determine the prevalence of normal tension glaucoma (NTG) in newly-diagnosed subjects with different stages of obstructive sleep apnea (mild, moderate, and severe)

Time frame
2 years
2

Mean difference in diagnostic parameters at baseline

Mean difference in pattern electroretinogram (PERG) parameters (in millivolts) and optical coherence tomography angiography (OCTA) Vessel density (VD) measurements at baseline between the 3 OSA study groups (mild, moderate, and severe).Magnitude (mV), MagnitudeD (MagD) (mV), MagD/Mag ratio and VD (%) will be compared across 3 OSA groups

Time frame
2 years
3

Mean change in diagnostic parameters at follow up intervals

Mean change in PERG parameters (in millivolt) and OCTA vessel density measurements (%) in each of the follow up visits compared to baseline

Time frame
2 years
4

Two PERG devices will be compared in their ability to detect retinal ganglion cell dysfunction

Diopsys NOVA PERG parameters will be correlated with PERG SmartEP parameters (in millivolts)

Time frame
2 years

Secondary outcomes

1

Incidence of NTG in female subjects

Incidence of NTG in female subjects

Time frame
2 years
2

Correlation of polysomnography and Epworth Sleeping Scale measures with PERG (Mag,MagD in millivolts, MagD/Mag ratio)and OCTA VD (%) measurements

Correlation of day time sleepiness from the Epworth scale (in points), polysomnography measures (apnea-hypopnea Index, in events/hour, saturation of oxygen, SaO2 in %, ), with PERG Mag, MagD in mV, MagD/Mag ratio and OCTA VD (in %) measurements

Time frame
2 years
3

Correlations between PERG parameters, Ocular Perfusion Pressure (OPP) and corneal hysteresis

Correlations between Mag, magD (in mV) and MagD/Mag ration, OPP measured by Falck device (mm Hg) , and corneal hysteresis (mm Hg), provided by ocular response analyzer, will be assessed

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: