Non-Invasive Retinal Assessment for Retinal Disease

Overseen By Jan M Full, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Randy Kardon

Disqualifiers: Cataract, Retinal abnormalities, Optic nerve issues, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new technology called LSFG-NAVI (Laser Speckle Flowgraphy) to examine the eye and identify issues in the retina's structure and function. The aim is to compare this technology to other vision tests, particularly in individuals with certain eye conditions. Suitable participants have either a normal eye exam from the past two years or specific retinal issues such as ischemic optic neuropathy, AZOOR, or related conditions. Those with mild cataracts may participate unless the cataract affects imaging. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in eye health technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technology is safe for retinal assessment?

Research shows that LSFG-NAVI, a tool for checking blood flow in the eye, is safe for people. Studies have found that the method behind LSFG-NAVI, called laser speckle flowgraphy (LSFG), has been used safely in patients with various eye conditions. These studies reported no major side effects, suggesting that LSFG-NAVI is well-tolerated. The procedure is non-invasive, meaning it doesn't involve surgery or entering the body, which generally enhances its safety. Overall, existing research supports the safety of LSFG-NAVI for checking eye health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LSFG-NAVI technique for retinal diseases because it offers a non-invasive way to assess retinal blood flow, setting it apart from current options that often require more invasive methods like fluorescein angiography. Unlike these standard procedures, which involve injecting a dye into the bloodstream, LSFG-NAVI uses laser speckle flowgraphy to measure blood flow directly and safely. This innovative approach not only reduces patient discomfort but also provides real-time data that could enhance early detection and monitoring of retinal conditions.

What evidence suggests that LSFG-NAVI is effective for retinal disease?

Research has shown that LSFG-NAVI, the investigational method studied in this trial, effectively measures blood flow changes in the eye. This method helps identify problems in individuals with eye conditions such as diabetic retinopathy (a diabetes-related eye issue) and retinal vein occlusion (a blockage in the eye's veins). Studies have found that LSFG-NAVI provides reliable results for checking blood flow in individuals with glaucoma, which is crucial for monitoring the disease. The technology also effectively detects blood flow differences in patients with age-related macular degeneration, a condition that leads to vision loss. Overall, LSFG-NAVI offers a non-invasive way to accurately assess eye health. ^{6 7 8 9 10}

Who Is on the Research Team?

Randy H Kardon, MD, PhD

Principal Investigator

University of Iowa Department of Ophthalmology

Are You a Good Fit for This Trial?

This trial is for people with certain eye conditions like Ischemic Optic Neuropathy, Retinal Artery Occlusion, and Leber's Optic Atrophy. Participants should have had a normal eye exam in the last two years and can't have severe cataracts or other issues that would affect retinal imaging.

Inclusion Criteria

It seems like there might be some confusion or a mix-up in the provided criterion. The statement seems to be discussing the total number of subjects in a study and the reasons for exclusion. It mentions the need for 450 participants, including 50 controls and 400 patients. It also refers to a situation where a subject might blink too much or have difficulty focusing during an imaging test. If you need assistance with a different criterion or further clarification, please feel free to provide more details.

I have a specific eye condition affecting my vision.

I have mild cataracts or clear vision that doesn't affect detailed eye scans.

Exclusion Criteria

I have a cataract or eye condition that does not severely affect retina imaging.

My eyesight is affected by an abnormal retina or optic nerve.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LSFG-NAVI

Trial Overview The study is testing LSFG-NAVI, a new non-invasive technology to examine the retina's structure and function. It aims to identify abnormal areas by comparing this method with other visual tests in subjects with inner or outer retinal defects.

How Is the Trial Designed?

Group I: Laser Speckle Blood Flow Group Experimental Treatment 1 Intervention

LSFG-NAVI is already approved in United States, Japan for the following indications:

Approved in United States as LSFG-NAVI for:

• Assessment of retinal structure and function
• Detection of inner and outer retinal defects

Approved in Japan as LSFG-NAVI for:

• Assessment of retinal microcirculation
• Diagnosis of glaucoma and other optic nerve diseases

Who Is Running the Clinical Trial?

Randy Kardon

Lead Sponsor

Trials

4

Recruited

1,100+

Published Research Related to This Trial

In a study of 15 healthy Japanese subjects, retinal blood flow velocities measured by laser speckle flowgraphy (LSFG) and retinal function imager (RFI) showed strong positive correlations, indicating that both methods can effectively assess retinal blood flow.

While LSFG provided similar blood flow velocities in arteries and veins, the RFI showed significant differences between these vessels, suggesting that LSFG may offer a more consistent measurement across different retinal regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COMPARISON OF THE RETINAL BLOOD FLOW VELOCITY BETWEEN LASER SPECKLE FLOWGRAPHY AND THE RETINAL FUNCTION IMAGER. Yuda, K., Ishida, A., Yuda, K.[2018]

Laser speckle flowgraphy (LSFG) is a noninvasive imaging technique that effectively visualizes and measures blood flow in the posterior part of the eye, including the retina, choroid, and optic nerve head.

This review highlights LSFG's advantages over other retinal imaging technologies and emphasizes the need for further research to enhance its diagnostic capabilities and integrate it with other methods for assessing chorioretinal circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the laser speckle flowgraphy in posterior fundus circulation research. Zhang, W., Kogure, A., Yamamoto, K., et al.[2012]

The study demonstrated that relative flow volume (RFV) measurements from laser speckle flowgraphy (LSFG) are highly accurate and reproducible, showing a strong correlation with traditional laser Doppler velocimetry (LDV) measurements of retinal blood flow.

With a coefficient of variation of only 5.9%, RFV can be considered a reliable index for assessing blood flow in the retina, making it a promising tool for evaluating changes in retinal blood flow related to ocular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative flow volume, a novel blood flow index in the human retina derived from laser speckle flowgraphy. Shiga, Y., Asano, T., Kunikata, H., et al.[2022]

Laser speckle flowgraphy (LSFG) is a non-contact technique that accurately measures blood flow in various parts of the eye, including the optic nerve head and retina, using advanced imaging technology.

The method provides reliable blood flow estimates through indices like normalized blur (NB) and square blur ratio (SBR), with SBR being a more precise measurement, although results should not be compared across different eyes due to their arbitrary units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of laser speckle flowgraphy in ocular blood flow research. Sugiyama, T., Araie, M., Riva, CE., et al.[2022]

Laser speckle flowgraphy (LSFG) demonstrated that healthy individuals have symmetrical blood flow in the fundus, indicating its potential as a reliable diagnostic tool.

In patients with internal carotid artery occlusion (ICAO), LSFG effectively detected disparities in ocular blood flow, showing high sensitivity (100%) and specificity (93.8%) for identifying ocular ischemic syndrome (OIS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Fundus Blood Flow in Normal Individuals and Patients with Internal Carotid Artery Obstruction Using Laser Speckle Flowgraphy. Shinohara, Y., Kashima, T., Akiyama, H., et al.[2018]

The study demonstrated that the modified laser speckle flowgraphy (LSFG-NAVI) technique has excellent intrasession reproducibility for measuring mean blur rate (MBR) in the optic disk and choroid of glaucoma patients, with high intraclass correlation coefficients (ICC) of 0.95 and 0.98, respectively.

Reproducibility was moderate for the retinal artery and vein, indicating that LSFG-NAVI is particularly reliable for assessing retinal circulation in the optic disk, which is crucial for monitoring glaucoma progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility of retinal circulation measurements obtained using laser speckle flowgraphy-NAVI in patients with glaucoma. Aizawa, N., Yokoyama, Y., Chiba, N., et al.[2022]

In a study of 35 patients with diabetic retinopathy, panretinal photocoagulation (PRP) significantly reduced retinal blood flow, as measured by laser speckle flowgraphy, indicating a potential mechanism of action for the treatment.

After PRP treatment, 82.85% of eyes showed regression of neovascular activity at 6 months, suggesting that monitoring retinal blood flow could help evaluate the effectiveness of PRP in managing diabetic retinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of retinal blood flow before and after panretinal photocoagulation using pattern scan laser for diabetic retinopathy. Yamada, Y., Suzuma, K., Onizuka, N., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2162098923002633

Recent Clinical Applications of Laser Speckle Flowgraphy ... Laser speckle flowgraphy is a valuable way of evaluating the time course of changes in ocular blood flow caused by ischemic retinal diseases such as DR or RVO.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3162298/

Reproducibility of retinal circulation measurements ... Laser speckle flowgraphy (LSFG) enables noninvasive quantification of the retinal circulation in glaucoma patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04014933

Reproducibility of Blood Flowmetry in Human Retina Using ... In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002939425000285

Laser Speckle Flowgraphy Reveals Widespread ... Laser speckle flowgraphy showed lower choroidal and inner retinal blood flow in non-exudative AMD patients compared to age-matched controls, not explained by ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996942/

Assessment of Time Lag Between Blood Flow, Retinal ... This study investigates the temporal relationship between blood flow changes and alterations in retinal nerve fiber layer thickness (RNFLT) and mean deviation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6239003/

Noninvasive Assessment of Retinal Blood Flow Using a ... We assessed the image quality and reproducibility of blood flow measurements from a novel handheld laser speckle imager in handheld and ...

7. withpower.com withpower.com/trial/phase-retinal-artery-occlusion-4-2019-20e35

Non-Invasive Retinal Assessment for Retinal Disease Laser speckle flowgraphy (LSFG) is a non-invasive method used to measure blood flow in the eye, and it has been used safely in studies involving patients with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11704823/

Evaluating blood flow patterns in the optic nerve head and ... Purpose. To compare blood flow (BF) impairment patterns in different optic neuropathies using laser speckle flowgraphy (LSFG). Methods.

9. mdpi.com mdpi.com/2304-6732/1/3/220

Basic Technology and Clinical Applications of the Updated ... Laser speckle flowgraphy (LSFG) allows for the quantitative estimation of blood flow in the optic nerve head (ONH), choroid and retina in vivo, utilizing the ...

10. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1093686/full

Ocular blood flow evaluation by laser speckle flowgraphy ... We measured the optic nerve head (ONH) and choroidal circulation using laser speckle flowgraphy (LSFG) and analyzed the choroidal mean blur rate (MBR-choroid).