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

NCT06023927 | Not Yet Recruiting

• 1 other identifier: 21-0958-MEETH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Normal Tension Glaucoma; Obstructive Sleep Apnea

Keywords

Glaucoma, obstructive sleep apnea Syndrome

Outcome Measures

Primary Outcomes (4)

• 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)

  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

  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

  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)

  2 years

Secondary Outcomes (3)

• Incidence of NTG in female subjects

  2 years

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

  2 years

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

  2 years

Study Arms (3)

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.

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.

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.

Other: Clinical observation, diagnostic testing

Interventions

Clinical observation, diagnostic testing OTHER

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

Newly-diagnosed mild OSA - initiating CPAP treatment; Newly-diagnosed moderate OSA - initiating CPAP treatment; Newly-diagnosed severe OSA - initiating CPAP treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly-diagnosed OSA patients that will undergo CPAP treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

Manhattan Eye, Ear, & Throat Hospital

New York, New York, 10065, United States

Location

Manhattan Eye, Ear, & Throat Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Low Tension Glaucoma; Sleep Apnea, Obstructive; Glaucoma

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: September 5, 2023
• Study Start: September 2, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

US (2)