Imaging Systems for Retinal Disease

(COCO-IRD Trial)

Overseen By Angie Adler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Advanced cataracts, Corneal disorders, Nystagmus, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new eye imaging systems, Clarus imaging and Optos imaging, to determine if they perform as well as the current leading system, Spectralis FAF imaging, for examining the back of the eye. The focus is on inherited retinal diseases (IRDs), which are genetic conditions affecting vision. Participants will have their eyes dilated and pictures taken with three different cameras to compare results. The trial seeks adults with a confirmed diagnosis of an IRD who are willing to undergo these eye tests. As an unphased trial, it offers participants the chance to contribute to advancing eye imaging technology for better diagnosis and treatment of IRDs.

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 seems focused on eye imaging, so it's unlikely that your medications would interfere, but you should confirm with the trial organizers.

What prior data suggests that these imaging systems are safe for evaluating retinal diseases?

Research shows that the imaging systems being tested—Clarus, Optos, and Spectralis FAF imaging—are generally safe for people. These systems capture images of the back of the eye.

Spectralis FAF imaging has been used for conditions like age-related macular degeneration. Studies have employed this system to monitor eye diseases without reporting safety issues.

Clarus and Optos imaging systems also assess eye health. They provide wide-angle images of the retina, aiding doctors in understanding eye conditions. No strong evidence suggests these systems cause harm.

Overall, these imaging technologies are well-tolerated and have been used in eye care for some time. No major reports of problems have emerged from using these cameras in similar settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these imaging systems for retinal disease because they offer new ways to visualize the retina that could lead to earlier and more accurate diagnoses. Unlike traditional imaging methods, Clarus, Optos, and Spectralis FAF imaging provide ultra-widefield views and detailed autofluorescence images, which can reveal subtle changes in retinal health. This enhanced imaging capability helps doctors detect diseases like macular degeneration and diabetic retinopathy at earlier stages, potentially improving patient outcomes.

What evidence suggests that these imaging systems are effective for evaluating retinal diseases?

This trial will evaluate the effectiveness of different imaging systems for retinal disease, including fundus autofluorescence (FAF) imaging. Research has shown that FAF imaging is a useful tool for examining eye conditions. Studies have found that FAF can reveal changes in the eye not visible with regular color images. It helps identify important changes in the retina, which are key to understanding inherited eye diseases. Previous research used FAF to monitor these changes over time in patients with retinal problems. Spectralis FAF imaging, in particular, combines this mapping with clear, detailed images, offering valuable insights into eye health. This makes it a promising method for evaluating retinal diseases. ^{1 2 4 6 7}

Who Is on the Research Team?

Kimberly Stepien, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals with inherited retinal diseases. Participants will have their eyes dilated and photographed using three different cameras to compare imaging systems.

Inclusion Criteria

Participants willing to participate as evidenced by signing the written informed consent

I am 18 or older with a diagnosed inherited retinal disease.

Exclusion Criteria

Patients unable to tolerate ocular imaging

Patients with advanced IRDs who are unable to fixate for imaging

I do not want to participate in the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo pupillary dilation and have photographs taken of the inside of the eyes using three different cameras

Up to 2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any immediate reactions or issues post-imaging

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Clarus imaging
• Optos imaging
• Spectralis FAF imaging

Trial Overview The study compares two ultrawide field cameras, Clarus and Optos, against the gold standard Spectralis FAF imaging system to see if they provide similar results in evaluating IRDs.

How Is the Trial Designed?

Group I: Fundus autofluorescence (FAF) imaging Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

The Optos P200DTx fundus camera captured significantly more retinal pixels and a larger total retinal area compared to the Zeiss Clarus 500, with results showing 510.4 pixels versus 355.6 pixels and 765.6 mm² versus 566.5 mm² respectively, indicating its superior imaging capability.

Despite the differences in imaging performance, there was no significant preference between the two devices among patients and technicians, nor was there a notable difference in the average time taken for imaging sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative Comparison of Fundus Images by 2 Ultra-Widefield Fundus Cameras. Chen, A., Dang, S., Chung, MM., et al.[2022]

The Optos(®) Optomap(®) imaging system captures a significantly larger total retinal area compared to the Heidelberg Spectralis(®) system, averaging 151,362 pixels versus 101,786 pixels, indicating its efficacy in providing a broader view of the retina.

While the Optos(®) system excels in imaging the nasal and temporal regions of the retina, the Heidelberg Spectralis(®) is better at capturing the superior and inferior retinal vasculature more peripherally, suggesting that both systems have unique strengths in retinal imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ultra-widefield fluorescein angiography with the Heidelberg Spectralis(®) noncontact ultra-widefield module versus the Optos(®) Optomap(®). Witmer, MT., Parlitsis, G., Patel, S., et al.[2022]

Fundus autofluorescence (FAF) imaging provides a unique way to visualize metabolic changes and structural alterations in the retina that traditional color imaging cannot detect, enhancing the diagnosis of various eye conditions.

FAF has proven effective in diagnosing and managing several chorioretinal diseases, including age-related macular degeneration and inherited retinal degenerations, highlighting its growing importance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fundus Autofluorescence and Clinical Applications. Pole, C., Ameri, H.[2022]

In a study involving 157 patients with diabetes, the UWF Clarus fundus imaging method demonstrated superior performance in detecting early diabetic retinopathy (DR) lesions compared to conventional five-field and UWF Optos imaging methods.

The agreement in DR severity grading was significantly higher between the five-field method and covered Clarus images, indicating that Clarus imaging is more effective for assessing early DR severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of early diabetic retinopathy severity using ultra-widefield Clarus versus conventional five-field and ultra-widefield Optos fundus imaging. Xiao, Y., Dan, H., Du, X., et al.[2023]

The modified Heidelberg Spectralis successfully performed ultra-widefield fundus fluorescein angiography in 11 infants, allowing for comprehensive imaging of both the posterior pole and peripheral retina in just one shot.

This technique proved to be effective and reliable, with a mean image acquisition time of 7.09 minutes, and offers a high-quality alternative to traditional RetCam angiography for infants undergoing examination under general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heidelberg Spectralis ultra-widefield fundus fluorescein angiography in infants. Fung, TH., Yusuf, IH., Xue, K., et al.[2015]

In a study of 202 patients, UWF-Clarus fundus imaging demonstrated excellent agreement with the ETDRS severity scale for diagnosing diabetic retinopathy (DR), suggesting it could be a superior method for assessing DR severity compared to traditional methods.

UWF-Clarus imaging revealed significantly more peripheral lesions than UWF-Optos imaging, indicating that it may detect more severe cases of DR, with potential implications for improving diagnosis and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of quantitative assessment and efficiency of diabetic retinopathy diagnosis using ETDRS seven-field imaging and two ultra-widefield imaging. Xiao, Y., Huang, Z., Yuan, Q., et al.[2023]

The ClarusTM imaging system demonstrated a high sensitivity of 94.4% in detecting neovascular age-related macular degeneration (AMD), making it a superior tool compared to Optos® (81.1%) and digital fundus photographs (87.8%).

ClarusTM also showed strong specificity (89.5%), indicating it is effective not only in identifying AMD but also in correctly ruling out normal cases, which is crucial for early detection and timely treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration. Maruyama-Inoue, M., Kitajima, Y., Mohamed, S., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0014483525002714

Fundus autofluorescence intensity, lifetime, and spectral ... This review covers the history, physics, and clinical applications of fundus autofluorescence imaging (FAF) in age-related macular degeneration (AMD).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8358768/

Fundus Autofluorescence and Clinical Applications - PMC Fundus autofluorescence (FAF) has allowed in vivo mapping of retinal metabolic derangements and structural changes not possible with conventional color imaging.

3. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(24)00188-X/fulltext

Quantification of Fundus Autofluorescence Features in a ... To quantify relevant fundus autofluorescence (FAF) features cross-sectionally and longitudinally in a large cohort of patients with inherited retinal diseases ( ...

4. business-lounge.heidelbergengineering.com business-lounge.heidelbergengineering.com/us/en/products/spectralis/spectralis/

SPECTRALIS OCT - The modular Imaging Platform The SPECTRALIS system is an expandable diagnostic imaging platform which combines scanning laser fundus imaging with high-resolution OCT.

5. medrxiv.org medrxiv.org/content/10.1101/2024.03.24.24304809v2.full.pdf

Quantification of Fundus Autofluorescence Features in a ... Veins and Arteries vessels. All visible retinal vessels stemming from the optic disc. Only annotated over atrophy if the grader is more than 50% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12309597/

Retinograd-AI: An Open-Source Automated Fundus ... To develop an automated system for assessing the quality of fundus autofluorescence (FAF) images in patients with inherited retinal diseases (IRDs).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6778681/

Use of Fundus Autofluorescence Combined with Optical ... The aim of this study was to demonstrate the sensitivity of Optical coherence tomography (OCT) in detection of geographic atrophy (GA) secondary to exudative ...