Eye Imaging for Glaucoma

Overseen By Harry A Quigley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Inability to perform imaging, illiterate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if images of the optic nerve, taken at two different eye pressures, can predict the progression of glaucoma, a condition that damages the eye's optic nerve. Participants will have their eyes photographed twice, each time at a different pressure. The trial seeks individuals who are already glaucoma patients at Johns Hopkins. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance glaucoma management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging technique is safe for eye examination?

Research has shown that eye imaging is safe. It involves no invasive methods or medications, using cameras to capture images of the eyes. In this trial, the only difference is that images are taken at two different eye pressures.

No evidence indicates any major safety concerns with this type of imaging. It resembles regular eye exams. Some individuals might experience mild discomfort when their eye pressure changes, but this typically subsides quickly and is not harmful.

Overall, eye imaging is well-tolerated. It is a common practice in eye care and carries minimal risk.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to understand and manage glaucoma by using advanced imaging techniques. Unlike current treatments that mainly focus on lowering eye pressure with medications or surgery, this approach aims to enhance diagnosis and monitoring by examining the eye at different pressures. The potential to capture detailed images at varying eye pressures could lead to earlier detection and more personalized treatment strategies, making it a promising development in the fight against glaucoma.

What evidence suggests that this imaging method is effective for predicting the course of glaucoma?

In this study, researchers take pictures of the optic nerve head, where the eye's nerve fibers converge. Participants will have images captured at two different eye pressures to help predict glaucoma development. Glaucoma harms the eye's optic nerve and can lead to vision loss. Changes in the optic nerve, visible in these pictures, may indicate early signs of damage. Although this method is new, it builds on existing knowledge of how pressure affects the eye to find clues about future eye health.

Who Is on the Research Team?

Harry A Quigley, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for current glaucoma patients at Johns Hopkins who can undergo imaging tests. It's not suitable for those who are illiterate, hearing impaired, or don't speak English.

Inclusion Criteria

Existing glaucoma patients of Johns Hopkins

Exclusion Criteria

Illiterate

I cannot undergo imaging tests.

I have hearing difficulties.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants are imaged with an FDA-approved optical coherence tomography instrument at two different eye pressures to generate biomechanical strain estimates

1-2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in visual field and retinal nerve fiber layer measurements over time

Approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Images of eye at 2 eye pressures

Trial Overview The study aims to see if images of the optic nerve head taken at two different eye pressures can predict how glaucoma will progress in a patient.

How Is the Trial Designed?

Group I: All subjects Experimental Treatment 1 Intervention

Each subject will be imaged at two different times and eye pressures

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

Ocular imaging tools are increasingly used in clinical practice to assess structural and functional damage in glaucoma, enhancing the reliability of early diagnosis.

Recent advancements in imaging technologies, such as improved scanning speed and depth, allow for better detection of glaucoma pathology, potentially leading to earlier intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating glaucoma damage: emerging imaging technologies. Kostanyan, T., Wollstein, G., Schuman, JS.[2020]

In a study involving 48 subjects and 76 eyes, there was poor agreement between visual field (VF) progression and scanning laser polarimetry (SLP) progression detection methods, indicating that these methods may not reliably identify glaucoma progression together.

The study suggests that neither population-derived nor individual-derived cut-off criteria for SLP effectively matched VF progression, leading to the recommendation of acquiring three SLP scans per visit to improve detection accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of glaucoma progression by population and individual derived variability criteria. Folio, LS., Wollstein, G., Kotowski, J., et al.[2021]

Chronic open-angle glaucoma is typically a slowly progressive disease, but eyes with very high intraocular pressure (IOP > 30 mmHg) require intensive treatment and monitoring to prevent damage.

The primary goal of glaucoma treatment is to prevent damage to the eye's structures and function, with effectiveness assessed through imaging and visual field tests, as glaucomatous changes can progress over several years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Finnish evidence-based guideline for open-angle glaucoma. Tuulonen, A., Airaksinen, PJ., Erola, E., et al.[2019]

In a study of 60 glaucoma patients and 61 normal controls, glaucomatous eyes exhibited significantly greater outward applanation velocity and peak distance, indicating altered corneal biomechanical properties compared to normal eyes.

The time to highest concavity was shorter in glaucomatous eyes and was found to be an independent marker of increased susceptibility to pressure, not correlated with age, intraocular pressure, or central corneal thickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Parameter of Corneal Biomechanics That Differentiate Normals From Glaucoma. Lee, R., Chang, RT., Wong, IY., et al.[2018]

In a study of 54 glaucoma patients, there was only fair agreement (65%) between the Heidelberg retina tomograph (HRT II) and expert clinical assessments of optic nerve head stereophotographs regarding disease progression.

The HRT II showed improved sensitivity (from 70% to 78%) and specificity (from 63.6% to 70%) after analysis, but its results should not be used alone to change treatment; they must be considered alongside other clinical indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of glaucoma progression evaluated with Heidelberg retina tomograph II versus optic nerve head stereophotographs. Kourkoutas, D., Buys, YM., Flanagan, JG., et al.[2016]

In a study involving 9 patients with primary open-angle glaucoma and 3 normal controls, trabeculectomy (TE) significantly relieved strain in the optic nerve head (ONH) by an average of 8.6%, compared to only 1.07% in normal controls, indicating that TE effectively reduces ONH strain in glaucoma patients.

The research found a linear relationship between the effective strain relief of the lamina cribrosa (LC) and retinal sensitivity, suggesting that greater strain relief is associated with lower retinal sensitivity, highlighting the complex biomechanics of the ONH in glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Vivo 3-Dimensional Strain Mapping of the Optic Nerve Head Following Intraocular Pressure Lowering by Trabeculectomy. Girard, MJ., Beotra, MR., Chin, KS., et al.[2022]

The Goldmann applanation tonometer, while the current gold standard for measuring intraocular pressure (IOP) in glaucoma patients, lacks the precision needed to detect changes as small as 1 mm Hg, which can significantly impact visual field prognosis.

Newer tonometers, such as the dynamic contour tonometer and rebound tonometer, may offer improved accuracy over the Goldmann tonometer by considering factors like corneal topography and elasticity, which are not fully accounted for in traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of true intraocular pressure: the gap between theory and practical data. Chihara, E.[2022]

Imaging techniques like optical coherence tomography (OCT) and laser scanning tomography are effective in measuring the structural progression of glaucoma, particularly the loss of the neuroretinal rim and retinal nerve fiber layer.

The most significant changes occur in the temporal region of the optic disc, with annual losses of only 6-7 µm in the retinal nerve fiber layer, highlighting the need for careful monitoring by ophthalmologists to differentiate between glaucoma-related changes and age-related loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Structural diagnostics of course observation for glaucoma]. Mardin, CY.[2021]

This study introduces a noninvasive method to measure individual eye stiffness, which can vary among subjects, challenging the assumption that all eyes have the same structural stiffness when measuring intraocular pressure (IOP) for glaucoma diagnosis.

The findings suggest that conventional applanation tonometry may misestimate IOP in individuals with abnormal eye stiffness, highlighting the importance of incorporating eye stiffness measurements for more accurate glaucoma detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact-based stiffness sensing of human eye. Kurita, Y., Kempf, R., Iida, Y., et al.[2009]

Citations