Clinical trial NCT06023927: Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness
Official title: Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Normal Tension Glaucoma
Obstructive Sleep Apnea
Keywords: Glaucoma, obstructive sleep apnea Syndrome
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly-diagnosed OSA patients that will undergo CPAP treatment

Brief summary: 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.

Detailed description: Glaucoma is a leading cause of irreversible blindness worldwide. Normal tension glaucoma (NTG) is a challenging subtype in which progressive changes to the optic nerve and retinal ganglion cell (RGC) function occur despite normal intraocular pressures (IOP). In most types of glaucoma, elevated IOP is the major risk factor and a key target for medical therapy. The absence of IOP elevation in NTG poses diagnostic dilemmas and therapeutic challenges. The disease is often diagnosed late, with irreversible atrophic changes to the optic nerve and permanent loss of vision. These clinically manifested structural and functional changes seen on optical coherence tomography (OCT) and visual field (VF) tests are likely preceded by a subclinical stage at which RGCs become increasingly dysfunctional before dying.

Obstructive sleep apnea (OSA) is characterized by intermittent nocturnal upper airway collapse, leading to oxygen deprivation and hypoxemia. It is a common cause of daytime sleepiness and is associated with an increased likelihood of hypertension, cardiovascular disease, stroke, and diminished quality of life. Continuous Positive Airway Pressure (CPAP) therapy is an established treatment for moderate to severe OSA in which patients sleep with a special mask that helps to regulate inspiratory and expiratory flow, alleviating hypoxia.

The investigators hypothesize that eliminating the hypoxia induced by OSA could have a favorable effect on retinal blood flow, thereby reducing the likelihood of progressive RGC damage and dysfunction in subjects at risk for NTG. The investigators are proposing a prospective, longitudinal, non-randomized study to evaluate the role of innovative diagnostic technologies in the early detection of NTG, and to establish its association with OSA. Additionally, the investigators will monitor the effects of OSA treatment in preventing the development of the disease, or at least halting its progression. Special attention will be given to the sex differences in the analysis to recognize the substantial differences in OSA between men and women, as well as the prevalence of NTG in different OSA severity groups.

While under the care of a Sleep Medicine physician, newly diagnosed subjects with OSA interested in participating will be recruited from the Northwell sleep center. Prior to initiating continuous positive airway pressure therapy (CPAP), consented participants will be screened to satisfying the eligibility criteria, and undergo a complete ophthalmological exam. Functional and structural diagnostic testing will be performed to evaluate baseline measures, including visual field testing, OCT, pattern electroretinography (PERG) and optical coherence tomography-angiography (OCTA) testing. Using the American Association of sleep Medicine (AASM) criteria, 3 groups will be formed based on the apnea-hypopnea index (AHI). The severity of OSA is graded as mild (AHI\<15), moderate (15\<AHI\<30), or severe (AHI\>30). The Epworth questionnaire will be used as part of routine clinical care to monitor improvement or deterioration after treatment. Once the baseline ophthalmological exam has been performed, subjects will return to the sleep center to begin CPAP therapy for OSA. Three follow up ophthalmic exams will be performed at 3, 6, and 9 months after initiating CPA therapy.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of NTG
timeFrame: 2 years
measure: Mean difference in diagnostic parameters at baseline
timeFrame: 2 years
measure: Mean change in diagnostic parameters at follow up intervals
timeFrame: 2 years
measure: Two PERG devices will be compared in their ability to detect retinal ganglion cell dysfunction
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of NTG in female subjects
timeFrame: 2 years
measure: Correlation of polysomnography and Epworth Sleeping Scale measures with PERG (Mag,MagD in millivolts, MagD/Mag ratio)and OCTA VD (%) measurements
timeFrame: 2 years
measure: Correlations between PERG parameters, Ocular Perfusion Pressure (OPP) and corneal hysteresis
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Eye, Ear, & Throat Hospital
state: New York
city: New York
country: United States
facility: Manhattan Eye, Ear, & Throat Hospital
state: New York
Study officials:
References: