Normal Tension GlaucomaNCT06023927
Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness
An observational study of Normal Tension Glaucoma and Obstructive Sleep Apnea, run by Northwell Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Normal Tension Glaucoma, Obstructive Sleep Apnea
- What is being tested?
- Clinical observation, diagnostic testing
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2025to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: Newly-diagnosed OSA patients that will undergo CPAP treatment
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Manhattan Eye, Ear, & Throat Hospital
New York, New York, 10065
Andrew Tirsi, MD, 201-982-4168, atirsi@northwell.edu
Celso Tello, MD
Manhattan Eye, Ear, & Throat Hospital
New York, New York, 10065
Andrew Tirsi, MD, 201-982-4168, atirsi@northwell.edu
Tirsi, atirsi@northwell.edu
About this study
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.
Read the 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.
- Conditions
- Normal Tension Glaucoma, Obstructive Sleep Apnea
- Being tested
- Clinical observation, diagnostic testing
- Keywords
- Glaucoma, obstructive sleep apnea Syndrome
- Medical subject headings
- Low Tension Glaucoma, Sleep Apnea, Obstructive, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical observation, diagnostic testingOther
Glaucoma evaluation including structural and functional diagnostic testing at baseline and 3 subsequent follow-up visits over a period of 9 months
| Study group | Role | What they receive |
|---|---|---|
| Newly-diagnosed mild OSA - initiating CPAP treatment | Subjects with newly-diagnosed mild obstructive sleep apnea being treated with CPAP undergoing clinical observation/diagnostic evaluation for detection and tracking of NTG. Receives: Other: Clinical observation, diagnostic testing | |
| Newly-diagnosed moderate OSA - initiating CPAP treatment | Subjects with newly-diagnosed moderate obstructive sleep apnea being treated with CPAP undergoing clinical observation/diagnostic evaluation for detection and tracking of NTG. Receives: Other: Clinical observation, diagnostic testing | |
| Newly-diagnosed severe OSA - initiating CPAP treatment | Subjects with newly-diagnosed severe obstructive sleep apnea being treated with CPAP undergoing clinical observation/diagnostic evaluation for detection and tracking of NTG. Receives: Other: Clinical observation, diagnostic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
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)
Measured: 2 years
Secondary outcomes (3)
Incidence of NTG in female subjects
Incidence of NTG in female subjects
Measured: 2 years
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
Measured: 2 years
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start2 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023927
- Sponsor's protocol ID
- 21-0958-MEETH
- Status last verified
- Jun 2025
- First submitted
- 12 Apr 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness
- ClinicalTrials.gov ID
- NCT06023927
- Acronym / sponsor ID
- 21-0958-MEETH
- Conditions
- Normal Tension Glaucoma, Obstructive Sleep Apnea
- Keywords
- Glaucoma, obstructive sleep apnea Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 2 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Newly-diagnosed mild OSA - initiating CPAP treatment | – | Other: Clinical observation, diagnostic testingSubjects with newly-diagnosed mild obstructive sleep apnea being treated with CPAP undergoing clinical observation/diagnostic evaluation for detection and tracking of NTG. |
| Newly-diagnosed moderate OSA - initiating CPAP treatment | – | Other: Clinical observation, diagnostic testingSubjects with newly-diagnosed moderate obstructive sleep apnea being treated with CPAP undergoing clinical observation/diagnostic evaluation for detection and tracking of NTG. |
| Newly-diagnosed severe OSA - initiating CPAP treatment | – | Other: Clinical observation, diagnostic testingSubjects with newly-diagnosed severe obstructive sleep apnea being treated with CPAP undergoing clinical observation/diagnostic evaluation for detection and tracking of NTG. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Newly-diagnosed OSA patients that will undergo CPAP treatment
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical observation, diagnostic testingGlaucoma evaluation including structural and functional diagnostic testing at baseline and 3 subsequent follow-up visits over a period of 9 months | Other | Newly-diagnosed mild OSA - initiating CPAP treatment, Newly-diagnosed moderate OSA - initiating CPAP treatment, Newly-diagnosed severe OSA - initiating CPAP treatment |
Primary outcome
Prevalence of NTG
Time frame: 2 years
To determine the prevalence of normal tension glaucoma (NTG) in newly-diagnosed subjects with different stages of obstructive sleep apnea (mild, moderate, and severe)
Mean difference in diagnostic parameters at baseline
Time frame: 2 years
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
Mean change in diagnostic parameters at follow up intervals
Time frame: 2 years
Mean change in PERG parameters (in millivolt) and OCTA vessel density measurements (%) in each of the follow up visits compared to baseline
Two PERG devices will be compared in their ability to detect retinal ganglion cell dysfunction
Time frame: 2 years
Diopsys NOVA PERG parameters will be correlated with PERG SmartEP parameters (in millivolts)
3 secondary outcomes
Incidence of NTG in female subjects
Time frame: 2 years
Correlation of polysomnography and Epworth Sleeping Scale measures with PERG (Mag,MagD in millivolts, MagD/Mag ratio)and OCTA VD (%) measurements
Time frame: 2 years
Correlations between PERG parameters, Ocular Perfusion Pressure (OPP) and corneal hysteresis
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Tension Glaucoma and Obstructive Sleep Apnea, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of NTG (time frame: 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.