Eye Imaging for Glaucoma

Recruiting in Palo Alto (17 mi)

Overseen by Harry A Quigley, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Inability to perform imaging, illiterate, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The investigators will test the hypothesis that images of the optic nerve head taken a 2 different eye pressures will yield strain estimates that are predictive of the course of glaucoma.

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 data supports the effectiveness of the treatment 'Images of eye at 2 eye pressures' for glaucoma?

The research highlights that ocular imaging tools are commonly used to assess structural and functional damage in glaucoma, suggesting that imaging at different eye pressures could help detect glaucoma more reliably and at earlier stages. Additionally, monitoring intraocular pressure (pressure inside the eye) is crucial for glaucoma treatment, and imaging can aid in evaluating the effectiveness of pressure-lowering treatments. ^{1 2 3 4 5}

How does this treatment for glaucoma differ from other treatments?

This treatment is unique because it uses advanced eye imaging to measure eye stiffness, which can vary between individuals and affect the accuracy of traditional methods for measuring eye pressure. By detecting these differences, it may help in the early detection of glaucoma, unlike conventional treatments that assume uniform eye stiffness. ^{2 6 7 8 9}

Research Team

Harry A Quigley, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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 do not speak English.

Trial Timeline

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

Treatment Details

Interventions

• Images of eye at 2 eye pressures (Device)

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.

Participant Groups

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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Dr. Michael F. Chiang

National Eye Institute (NEI)

Chief Executive Officer since 2020

MD from Harvard Medical School

Dr. Richard Lee

National Eye Institute (NEI)

Chief Medical Officer since 2021

MD, PhD from Harvard Medical School

Findings from Research

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of glaucoma progression evaluated with Heidelberg retina tomograph II versus optic nerve head stereophotographs. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Evaluating glaucoma damage: emerging imaging technologies. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Detection of glaucoma progression by population and individual derived variability criteria. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Denmark pubmed.ncbi.nlm.nih.gov

The Finnish evidence-based guideline for open-angle glaucoma. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

[Structural diagnostics of course observation for glaucoma]. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

In Vivo 3-Dimensional Strain Mapping of the Optic Nerve Head Following Intraocular Pressure Lowering by Trabeculectomy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Novel Parameter of Corneal Biomechanics That Differentiate Normals From Glaucoma. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Contact-based stiffness sensing of human eye. [2009]