Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05746975
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-18
First Post:
2023-02-06
Brief Title:
Diabetic Retinopathy Classification ETDRS 7-fields vs Widefield Imaging ClarusDR
Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Organization:
Association for Innovation and Biomedical Research on Light and Image
Study Overview
Official Title:
Diabetic Retinopathy Classification ETDRS 7-fields vs Widefield Imaging Clarus 500 and Optos California
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ClarusDR
Brief Summary:
The goal of this observational study is to analyse and compare Diabetic Retinopathy severity level using 30º ETDRS 7-fields and Wide-field Imaging techniques using Clarus 500 Carl Zeiss Meditech Inc Dublin USA and Optos Optos Dunfermline UK in diabetic patients with mild to moderate diabetic retinopathy The main questions it aims to answer are
1 To compare the Clarus 500TM wide-field imaging technique with the ETDRS 7-fields method in the assessment of DR severity level using the ETDRS DRSS2 To compare the two wide-field imaging techniques Clarus 500TM vs OptosTM in the assessment of DR severity level using the ETDRS DRSS3 To evaluate the peripheral area imaged by the wide-field Clarus 500TM and OptosTM to characterize DR lesions distribution predominantly observed within or outside the ETDRS 7-fields and severity according to the ETDRS standard photos4 To determine the relevance and frequency of DR PPL located outside the ETDRS 7-fields area and to explore PPL occurrence in different DR severity levels
Participants will undergo a non-invasive ophthalmological examination which includes BCVA 7-fields CFP and UWF FP to assess ETDRS DRSS level
1 To compare the Clarus 500TM wide-field imaging technique with the ETDRS 7-fields method in the assessment of DR severity level using the ETDRS DRSS2 To compare the two wide-field imaging techniques Clarus 500TM vs OptosTM in the assessment of DR severity level using the ETDRS DRSS3 To evaluate the peripheral area imaged by the wide-field Clarus 500TM and OptosTM to characterize DR lesions distribution predominantly observed within or outside the ETDRS 7-fields and severity according to the ETDRS standard photos4 To determine the relevance and frequency of DR PPL located outside the ETDRS 7-fields area and to explore PPL occurrence in different DR severity levels
Participants will undergo a non-invasive ophthalmological examination which includes BCVA 7-fields CFP and UWF FP to assess ETDRS DRSS level
Detailed Description:
Diabetic Retinopathy DR remains a significant cause of blindness in working-age populations across the world The gold-standard method for assessing its severity is the modified Airlie House classification developed for the Early Treatment Diabetic Retinopathy Study ETDRS still used by clinical trials for developing of DR therapeutic and management guidelines
ETDRS Diabetic Retinopathy Severity Score DRSS is based on the identification of DR lesions on colour fundus photographys CFP obtained in different locations of the retina The photography acquisition protocol consists in acquiring seven stereoscopic pairs of overlapping 30 fields images of the ocular fundus to map out the macula and mid-peripheral retina Photographers and fundus camera systems usually need training and certification by external reading centres to guarantee proper images quality and fields definition in a process that can be challenging with a considerable learning curve Patient collaboration to follow a fixation point in different locations and withstand intense flashes of light a good dilation of eye pupil and the difficulty to obtain well focused images in peripherical gaze positions are some of the main difficulties for obtaining gradable images using this 7-fields acquisition protocol
On the other side the grading process of ETDRS 7-fields images can be extremely labour-intensive and strongly dependent on the quality of the images presence of artifacts and the definition of the peripherical fields requiring well-trained people to identify and recognise features that can be very subtle or easily get unnoticed
Moreover the retinal area documented with the ETDRS 7-fields protocol represents approximately only 35 of the retina surface Substantial diabetic retinal pathology can exist in the retinal periphery located outside this area which is being emphasized by advanced retinal imaging technology Predominantly Peripheral Lesions PPL like the presence of venous beading new-vessels haemorrhages and microaneurysms in the extreme periphery have been correlated with peripheral non-perfusion neurodegenerative changes and consequent increase of DR progression
Recent instrumentation like OptosTM Optos Dunfermline UK or Clarus 500TM Carl Zeiss Meditech Inc Dublin USA allow wide-field acquisitions that document up to 90 of the retina surface in just one or two images decreasing patients tiredness and discomfort and overcoming most of the quality and fields definition issues described above
OptosTM equipment can acquire almost 200º of the retina in just one picture without the need for pupil dilation and using ultra-widefield scanning laser ophthalmoscopy SLO technology Its final image is based on the superimposition of two images acquired with 2 different laser wavelengths a green and a red wavelength giving a semirealistic colour image that despite its high contrast and sharpness gives the retina a greenish and unreal aspect Also its 200º field amplitude is usually disturbed by artifacts caused by the presence of eyelashes or eyelids that mainly obscure the peripherical area of the retina
On the other hand Clarus 500 TM equipment uses an imaging technique called Broad Line Fundus Imaging that is a hybrid of confocal SLO cSLO and traditional fundus photography This technology provides higher resolution images with more accurate coloration of the fundus A single image capture with this system obtains 133-degrees of view but with the acquisition of just two pictures a temporal and nasal image of the retina a 200-degree of view can be achieved
Several studies have suggested moderate to substantial agreement between Optos ultra-wide field UWF and ETDRS 7-fields imaging and have shown that DR occurs in areas peripheral to the ETDRS fields in up to 40 of eyes which may imply a more severe level of DR in 9 to 15 of eyes However there is only limited data regarding the validity of DR assessment using Clarus 500TM imagine technique obtained in cross-sectional studies with few patients
On this basis the aim of this work is to identify and compare the ETDRS severity level of diabetic patients using 3 different images modalities the 30º ETDRS 7-fields colour fundus photographys protocol the 2 wide-field images technique with Clarus 500 TM and the 1 wide-field image of OptosTM in a prospective longitudinal and randomized study The ETDRS 7-fields area will be superimposed on both wide-field equipments images so equivalent retinal areas will be analysed Our goal is to demonstrate that ETDRS severity level can be accurately evaluated using only two Clarus 500TM high quality images with wider amplitude decreasing the effort and collaboration skills that are required in older techniques while improving the quality and identification capability of key disease features with less artifacts than other wide-field systems Additionally peripheral retina outside the ETDRS 7-fields area will also be analysed to assess the presence of PPL and evaluate its relevance and association with disease severity level and progression
Finally the investigators expect to evaluate patients opinion about their experience in each imaging modality evaluating their discomfort and satisfaction degree while submitted to each procedure
ETDRS Diabetic Retinopathy Severity Score DRSS is based on the identification of DR lesions on colour fundus photographys CFP obtained in different locations of the retina The photography acquisition protocol consists in acquiring seven stereoscopic pairs of overlapping 30 fields images of the ocular fundus to map out the macula and mid-peripheral retina Photographers and fundus camera systems usually need training and certification by external reading centres to guarantee proper images quality and fields definition in a process that can be challenging with a considerable learning curve Patient collaboration to follow a fixation point in different locations and withstand intense flashes of light a good dilation of eye pupil and the difficulty to obtain well focused images in peripherical gaze positions are some of the main difficulties for obtaining gradable images using this 7-fields acquisition protocol
On the other side the grading process of ETDRS 7-fields images can be extremely labour-intensive and strongly dependent on the quality of the images presence of artifacts and the definition of the peripherical fields requiring well-trained people to identify and recognise features that can be very subtle or easily get unnoticed
Moreover the retinal area documented with the ETDRS 7-fields protocol represents approximately only 35 of the retina surface Substantial diabetic retinal pathology can exist in the retinal periphery located outside this area which is being emphasized by advanced retinal imaging technology Predominantly Peripheral Lesions PPL like the presence of venous beading new-vessels haemorrhages and microaneurysms in the extreme periphery have been correlated with peripheral non-perfusion neurodegenerative changes and consequent increase of DR progression
Recent instrumentation like OptosTM Optos Dunfermline UK or Clarus 500TM Carl Zeiss Meditech Inc Dublin USA allow wide-field acquisitions that document up to 90 of the retina surface in just one or two images decreasing patients tiredness and discomfort and overcoming most of the quality and fields definition issues described above
OptosTM equipment can acquire almost 200º of the retina in just one picture without the need for pupil dilation and using ultra-widefield scanning laser ophthalmoscopy SLO technology Its final image is based on the superimposition of two images acquired with 2 different laser wavelengths a green and a red wavelength giving a semirealistic colour image that despite its high contrast and sharpness gives the retina a greenish and unreal aspect Also its 200º field amplitude is usually disturbed by artifacts caused by the presence of eyelashes or eyelids that mainly obscure the peripherical area of the retina
On the other hand Clarus 500 TM equipment uses an imaging technique called Broad Line Fundus Imaging that is a hybrid of confocal SLO cSLO and traditional fundus photography This technology provides higher resolution images with more accurate coloration of the fundus A single image capture with this system obtains 133-degrees of view but with the acquisition of just two pictures a temporal and nasal image of the retina a 200-degree of view can be achieved
Several studies have suggested moderate to substantial agreement between Optos ultra-wide field UWF and ETDRS 7-fields imaging and have shown that DR occurs in areas peripheral to the ETDRS fields in up to 40 of eyes which may imply a more severe level of DR in 9 to 15 of eyes However there is only limited data regarding the validity of DR assessment using Clarus 500TM imagine technique obtained in cross-sectional studies with few patients
On this basis the aim of this work is to identify and compare the ETDRS severity level of diabetic patients using 3 different images modalities the 30º ETDRS 7-fields colour fundus photographys protocol the 2 wide-field images technique with Clarus 500 TM and the 1 wide-field image of OptosTM in a prospective longitudinal and randomized study The ETDRS 7-fields area will be superimposed on both wide-field equipments images so equivalent retinal areas will be analysed Our goal is to demonstrate that ETDRS severity level can be accurately evaluated using only two Clarus 500TM high quality images with wider amplitude decreasing the effort and collaboration skills that are required in older techniques while improving the quality and identification capability of key disease features with less artifacts than other wide-field systems Additionally peripheral retina outside the ETDRS 7-fields area will also be analysed to assess the presence of PPL and evaluate its relevance and association with disease severity level and progression
Finally the investigators expect to evaluate patients opinion about their experience in each imaging modality evaluating their discomfort and satisfaction degree while submitted to each procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None