Non-Invasive Retinal Assessment for Retinal Disease
Recruiting in Palo Alto (17 mi)
Overseen byRandy H Kardon, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Randy Kardon
Disqualifiers: Cataract, Retinal abnormalities, Optic nerve issues, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12367How 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.
13456Eligibility Criteria
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.
+2 more
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.
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Laser Speckle Blood Flow GroupExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Iowa Department of OphthalmologyIowa City, IA
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Who Is Running the Clinical Trial?
Randy KardonLead Sponsor
References
Reproducibility of retinal circulation measurements obtained using laser speckle flowgraphy-NAVI in patients with glaucoma. [2022]Laser speckle flowgraphy (LSFG) enables noninvasive quantification of the retinal circulation in glaucoma patients. In this study, we tested the intrasession reproducibility of LSFG-NAVI, a modified LSFG technique.
Evaluation of Fundus Blood Flow in Normal Individuals and Patients with Internal Carotid Artery Obstruction Using Laser Speckle Flowgraphy. [2018]We investigated whether laser speckle flowgraphy (LSFG) results are comparable in both eyes and whether it is useful in the diagnosis of disparity in ocular ischemic syndrome (OIS) patients.
Use of the laser speckle flowgraphy in posterior fundus circulation research. [2012]To review articles aiming to present an overview of the principles, progress, uses and limitations of laser speckle flowgraphy (LSFG) in posterior fundus circulation research.
Relative flow volume, a novel blood flow index in the human retina derived from laser speckle flowgraphy. [2022]We investigated the accuracy and reproducibility of relative flow volume (RFV), a novel index of blood flow in the human retina derived from laser speckle flowgraphy (LSFG).
Evaluation of retinal blood flow before and after panretinal photocoagulation using pattern scan laser for diabetic retinopathy. [2018]Laser speckle flowgraphy (LSFG) can measure blood flow in the ocular fundus. We analyzed the relationship between retinal blood flow and panretinal photocoagulation (PRP) in diabetic retinopathy.
Use of laser speckle flowgraphy in ocular blood flow research. [2022]Laser speckle flowgraphy (LSFG) allows for the quantitative estimation of blood flow in the optic nerve head, choroid, retina and iris in vivo. It was developed to facilitate the non-contact analysis of ocular blood flow in living eyes, utilizing the laser speckle phenomenon. The technique uses a fundus camera, a diode laser, an image sensor, an infrared charge-coupled device (CCD) camera and a high-resolution digital CCD camera. Normalized blur (NB), an approximate reciprocal of speckle contrast, represents an index of blood velocity, and shows a good correlation with tissue blood flow rates determined with the microsphere method in the retina, choroid or iris, as well as blood flow rates determined with the hydrogen gas clearance method in the optic nerve head. The square blur ratio (SBR), another index for quantitative estimation of blood velocity, is proportional to the square of the NB. The SBR is theoretically a more exact measurement which is proportional to velocity, whereas the NB is an approximation. Normalized blur was calculated in earlier versions of LSFG because of technical limitations; the SBR is used in current versions of the LSFG instrument. As these values are in arbitrary units, they should not be used to make comparisons between different eyes or different sites in an eye. Clinical protocols, calibration, evaluation procedures and possible limitations of the LSFG technique are described and the results of ocular blood flow studies using LSFG are briefly summarized. The LSFG method is suitable for monitoring the time-course of change in the tissue circulation at the same site in the same eye at various intervals, ranging from seconds to months. Unresolved issues concern the effect of pupil size on measurement results, the effects of various stimulations, and how to measure choroidal and retinal blood flow velocity separately without using the blue-component of argon laser.
COMPARISON OF THE RETINAL BLOOD FLOW VELOCITY BETWEEN LASER SPECKLE FLOWGRAPHY AND THE RETINAL FUNCTION IMAGER. [2018]To compare the retinal blood flow velocity using laser speckle flowgraphy (LSFG) and a retinal function imager (RFI) in healthy Japanese subjects.