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 study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.

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.

Is laser speckle flowgraphy (LSFG) safe for humans?

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 glaucoma and other eye conditions. No specific safety concerns have been reported in the available research. ^{1 2 3 4 5}

How is the LSFG-NAVI treatment different from other treatments for retinal disease?

LSFG-NAVI is unique because it is a non-invasive method that uses laser speckle flowgraphy to measure blood flow in the retina, allowing for precise monitoring of retinal circulation without direct contact with the eye. This makes it different from other treatments that may require invasive procedures or do not provide real-time blood flow data. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment LSFG-NAVI for retinal disease?

Research shows that LSFG-NAVI, a technique for measuring blood flow in the eye, is reproducible and accurate in assessing retinal circulation, which is important for conditions like glaucoma and diabetic retinopathy. This suggests it could be effective in monitoring and potentially managing retinal diseases. ^{2 3 4 6 7}

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

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]

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]

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]

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]

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]

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]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Reproducibility of retinal circulation measurements obtained using laser speckle flowgraphy-NAVI in patients with glaucoma. [2022]

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

Evaluation of Fundus Blood Flow in Normal Individuals and Patients with Internal Carotid Artery Obstruction Using Laser Speckle Flowgraphy. [2018]

3. China pubmed.ncbi.nlm.nih.gov

Use of the laser speckle flowgraphy in posterior fundus circulation research. [2012]

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

Relative flow volume, a novel blood flow index in the human retina derived from laser speckle flowgraphy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of retinal blood flow before and after panretinal photocoagulation using pattern scan laser for diabetic retinopathy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Use of laser speckle flowgraphy in ocular blood flow research. [2022]

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

COMPARISON OF THE RETINAL BLOOD FLOW VELOCITY BETWEEN LASER SPECKLE FLOWGRAPHY AND THE RETINAL FUNCTION IMAGER. [2018]