Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to compare measurements of geographic atrophy (GA) area between several types of imaging, in order to assess accuracy. The main question to answer is which imaging device provides measurements that are most similar to the standard of care device.
Participants will be patients of a retina doctor at University Station Eye Clinic with geographic atrophy, and can expect to be in the study for 60-75 minutes.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the idea that Imaging Comparison for Age-Related Macular Degeneration is an effective treatment?
The available research shows that the Clarus and Optos imaging systems are effective in detecting neovascular age-related macular degeneration (AMD) when compared to conventional digital fundus photographs. This suggests that these imaging methods can help in the early detection and management of AMD, which is crucial for effective treatment. While the studies also discuss the use of these imaging systems for diabetic retinopathy, the focus on AMD indicates their effectiveness in this specific condition.
12345What safety data exists for imaging methods used in age-related macular degeneration treatment?
The studies provided do not directly address safety data for the imaging methods used in age-related macular degeneration treatment. They focus on comparing the performance and effectiveness of different imaging systems, such as Optos and Clarus, in detecting retinal conditions like diabetic retinopathy and neovascular AMD. No specific safety concerns or adverse effects are mentioned in these studies.
12346Is the treatment in the trial 'Imaging Comparison for Age-Related Macular Degeneration' a promising treatment?
The treatment in the trial is promising because it uses advanced imaging techniques to better understand and track the progression of age-related macular degeneration. This can help doctors predict how the disease will develop and potentially improve how they manage and treat it in the future.
7891011Eligibility Criteria
This trial is for individuals over 50 with a specific eye condition called geographic atrophy due to age-related macular degeneration. Participants should have GA areas between 1.25 and 23 mm², which can be either subfoveal or extrafoveal. Those with neovascular AMD, other retinal diseases that could affect the study, or who cannot undergo eye imaging are not eligible.Inclusion Criteria
My eye condition affects a specific area size and can be in one or more spots.
I have been diagnosed with geographic atrophy due to age-related macular degeneration.
Willing to participate as evidenced by signing the written informed consent
+1 more
Exclusion Criteria
Unable to tolerate opthalmic imaging
My eye doctor confirmed I have wet AMD.
Presence of significant media opacity preventing adequate retinal imaging
+1 more
Participant Groups
The trial aims to compare three different eye imaging systems: Spectralis FAF, Optos, and Zeiss Clarus 700. It will determine which system's measurements of geographic atrophy area align most closely with the standard care device in patients visiting University Station Eye Clinic.
1Treatment groups
Experimental Treatment
Group I: Fundus autofluorescence (FAF) imagingExperimental Treatment3 Interventions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WisconsinMadison, WI
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Who Is Running the Clinical Trial?
University of Wisconsin, MadisonLead Sponsor
References
Sensitivity and specificity of high-resolution wide field fundus imaging for detecting neovascular age-related macular degeneration. [2020]Early detection and treatment are important management strategies for neovascular age-related macular degeneration (AMD). The purpose of this study was to determine the sensitivity and specificity in detecting neovascular AMD using two wide-field imaging systems: ClarusTM (CLARUS 500™, Carl Zeiss Meditec AG, Jena, Germany) and Optos®(Optos California®, Optos PLC, Dunfermline, United Kingdom), compared to conventional digital fundus photographs.
Assessment of early diabetic retinopathy severity using ultra-widefield Clarus versus conventional five-field and ultra-widefield Optos fundus imaging. [2023]To compare early diabetic retinopathy (DR) severity level and the abilities in detecting early DR lesions among conventional five-field, ultrawide-field (UWF) Optos, and UWF Clarus fundus imaging methods. This was a single-center, prospective, clinic-based, and comparative study. In total, 157 consecutive patients with diabetes mellitus were enrolled in this study. All patients underwent comprehensive ophthalmological examinations. Following mydriasis, each eye was examined with conventional five-field, UWF Optos, and UWF Clarus fundus imaging methods. The initial UWF images were overlaid with a template mask that obscured the retina, which created a five-field view from UWF images (covered UWF images). The covered UWF images were then graded, after which the template mask was removed, and the original UWF images were also evaluated. All images were graded using the International Clinical DR severity scale. DR grades were compared and analyzed by weighted kappa statistics among the three fundus imaging methods. In total, 157 consecutive patients with diabetes (302 eyes) were enrolled in this study. Weighted kappa statistics for agreement were 0.471 (five-field vs. covered Optos), 0.809 (five-field vs. covered Clarus), 0.396 (covered Optos vs. covered Clarus), 0.463 (five-field vs. Optos), 0.521 (five-field vs. Clarus 133°), 0.500 (five-field vs. Clarus 200°), 0.323 (Optos vs. Clarus 133°), and 0.349 (Optos vs. Clarus 200°). The area under curve of covered Clarus images was higher than that of conventional five-field images at three different thresholds. Compared with conventional five-field and Optos fundus imaging methods, Clarus fundus imaging methods exhibited excellent performance in assessing early DR severity. Thus, Clarus fundus imaging methods were superior for early detection of DR.
Quantitative Comparison of Fundus Images by 2 Ultra-Widefield Fundus Cameras. [2022]To compare the relative number of retinal pixels and retinal area imaged using the Optos P200DTx (Optos PLC) and Zeiss Clarus 500 (Carl Zeiss Meditec AG) ultra-widefield (UWF) fundus cameras.
Comparison of ultra-widefield fluorescein angiography with the Heidelberg Spectralis(®) noncontact ultra-widefield module versus the Optos(®) Optomap(®). [2022]To compare ultra-widefield fluorescein angiography imaging using the Optos(®) Optomap(®) and the Heidelberg Spectralis(®) noncontact ultra-widefield module.
Comparison of quantitative assessment and efficiency of diabetic retinopathy diagnosis using ETDRS seven-field imaging and two ultra-widefield imaging. [2023]This study compared the efficiency of diabetic retinopathy (DR) diagnosis and differences in the relative visible retinal area among the Early Treatment Diabetic Retinopathy Study (ETDRS) seven-field, ultra-widefield (UWF)-Optos, and UWF-Clarus fundus imaging methods.
Performance evaluation of two fundus oculi angiographic imaging system: Optos 200Tx and Heidelberg Spectralis. [2020]The present study aimed to compare the imaging performance of two ultra-wide-field fluorescein angiography imaging systems, namely the OptosOptomap 200Tx (Optos 200Tx) and the Heidelberg Spectralis (Spectralis). A total of 18 patients (36 eyes) underwent angiography using the two systems at the Department of Ophthalmology, Beijing Friendship Hospital (Beijing, China) between January and June 2017. The images were obtained as a single shot centered on the macula. The total area and area within each of four visualized quadrants were calculated and compared. The averages of the total and individual quadrant area captured by the Optos 200Tx were all larger than those obtained with the Spectralis (P<0.05). For pair-wise comparison, the circular area centered on the macula (radius of 10 and 15 mm) was displayed: Optos 200Tx 10 mm (295.57 mm2) < Spectralis (520.11 mm2) < Optos 200Tx 15 mm (596.45 mm2) < Optos 200Tx (804.36 mm2) (P<0.01). The differences of each of the four quadrant areas were statistically significant between the two systems (P<0.05). The mean size of the areas was in the following order: Inferior < temporal < superior < nasal for the Optos 200Tx, and inferior < temporal < nasal < superior for the Spectralis. Further comparison of the four-quadrant area indicated that the inferior quadrant of the Optos 200Tx was smaller than the other three quadrants (P<0.01) and the inferior quadrant of the Spectralis was smaller than the superior quadrant (P<0.01). The total retinal area and the retinal area of each quadrant captured by the Optos 200Tx were larger than those captured with the Spectralis. The total retinal area captured with the Optos 200Tx was able to cover the mid-peripheral area and part of the far-peripheral area of the retina, whereas the Spectralis only covered the mid-peripheral area.
Use of fundus autofluorescence images to predict geographic atrophy progression. [2021]Fundus autofluorescence imaging has been shown to be helpful in predicting progression of geographic atrophy (GA) secondary to age-related macular degeneration. We assess the ability of fundus autofluorescence imaging to predict rate of GA progression using a simple categorical scheme.
Combined grading for choroidal neovascularisation: colour, fluorescein angiography and autofluorescence images. [2018]Patients with age-related macular degeneration (ARMD) have several imaging techniques carried out regularly. In this study we introduce a new grading model of autofluorescence images (AF), compare it with fluorescein angiography (FFA) and digital colour fundus photos (COL) and test for inter- and intraobserver reliability.
ULTRAWIDEFIELD PSEUDOCOLOR RETINAL IMAGING VERSUS REAL-COLOR FUNDUS PHOTOGRAPHY FOR DETECTION OF INTRARETINAL PIGMENT MIGRATION IN AGE-RELATED MACULAR DEGENERATION. [2021]To compare pseudocolor Optos ultrawidefield (UWF) retinal images with conventional real-color fundus photography (CFP) for detecting macular hyperpigmentary changes in intermediate age-related macular degeneration.
[Topographic, 3D and Quantitative analysis of autofluorescence in dry, age-related macular degeneration]. [2009]Autofluorescence of the retina allows one to quantify and follow the extent and progression of dry, age-related macular degeneration (ARMD) changes. The objective of this study was to compare different analysis methods for displaying autofluorescence images.
Imaging geographic atrophy in age-related macular degeneration. [2022]Advances in retinal imaging technology have largely contributed to the understanding of the natural history, prognostic markers and disease mechanisms of geographic atrophy (GA) due to age-related macular degeneration. There is still no therapy available to halt or slow the disease process. In order to evaluate potential therapeutic effects in interventional trials, there is a need for precise quantification of the GA progression rate. Fundus autofluorescence imaging allows for accurate identification and segmentation of atrophic areas and currently represents the gold standard for evaluating progressive GA enlargement. By means of high-resolution spectral-domain optical coherence tomography, distinct microstructural alterations related to GA can be visualized.