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

Trial Summary

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 data supports the effectiveness of the treatment Clarus imaging, Clarus 500, Clarus 700, Zeiss Clarus, Optos imaging, Optos UWF imaging, Optos ultrawide field imaging, Optos Optomap, Spectralis FAF imaging, Spectralis Fluorescence Angiography, Spectralis Fundus Autofluorescence for retinal disease?

Research shows that Clarus fundus imaging methods are superior for early detection of diabetic retinopathy (DR) compared to conventional methods, and both Clarus and Optos imaging systems have high sensitivity and specificity for detecting neovascular age-related macular degeneration (AMD). ^{1 2 3 4 5}

Is ultra-widefield imaging safe for humans?

The studies on ultra-widefield imaging systems like Clarus and Optos do not report any safety concerns, suggesting they are generally safe for use in humans. ^{1 2 3 5 6}

How does the imaging treatment for retinal disease differ from other treatments?

This treatment uses advanced imaging systems like Clarus and Optos to detect retinal diseases early by capturing wide-field images of the retina, which is different from traditional methods that use narrower field imaging. These systems provide a more comprehensive view of the retina, potentially leading to earlier and more accurate diagnosis and management of conditions like age-related macular degeneration and diabetic retinopathy. ^{1 2 3 5 7}

What is the purpose of this trial?

The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs). Participants will: * undergo pupillary dilation * have photographs taken of the inside of the eyes using three different cameras

Research Team

Kimberly Stepien, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

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

Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration. [2020]

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

Quantitative Comparison of Fundus Images by 2 Ultra-Widefield Fundus Cameras. [2022]

3. England 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. [2023]

4. England 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. [2023]

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

Comparison of ultra-widefield fluorescein angiography with the Heidelberg Spectralis(®) noncontact ultra-widefield module versus the Optos(®) Optomap(®). [2022]

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

Heidelberg Spectralis ultra-widefield fundus fluorescein angiography in infants. [2015]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Fundus Autofluorescence and Clinical Applications. [2022]