Retinopathy, Diabetic Clinical Trial
— ClarusDROfficial title:
Diabetic Retinopathy Classification: ETDRS 7-fields vs Widefield Imaging (Clarus 500 and Optos California)
NCT number | NCT05746975 |
Other study ID # | 4C-2023-12 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 3, 2023 |
Est. completion date | August 2024 |
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 DRSS.2. To compare the two wide-field imaging techniques (Clarus 500TM vs OptosTM) in the assessment of DR severity level using the ETDRS DRSS.3. 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 photos).4. 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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | Inclusion Criteria: - DM type 2 according to 1985 World Health Organization (WHO) criteria - Age between 35 and 80 years - BCVA = 75 letters (20 /32) - Refraction with a spherical equivalent less than 5 Diopters - NPDR levels 35 and 43-47 (based on the ETDRS criteria - 7 fields CFP) Exclusion Criteria: - Cataract or other eye disease that may interfere with fundus examinations - Glaucoma - Other retinal vascular disease than DR - Refractive errors > to + or - 5 Diopters - Pupil diameter of less than 5 mm - Poor quality images due to artifacts, movements, or media opacities |
Country | Name | City | State |
---|---|---|---|
Portugal | AIBILI-CEC (AIBILI- Clinical Trials Centre) | Coimbra |
Lead Sponsor | Collaborator |
---|---|
Association for Innovation and Biomedical Research on Light and Image |
Portugal,
Aiello LP, Odia I, Glassman AR, Melia M, Jampol LM, Bressler NM, Kiss S, Silva PS, Wykoff CC, Sun JK; Diabetic Retinopathy Clinical Research Network. Comparison of Early Treatment Diabetic Retinopathy Study Standard 7-Field Imaging With Ultrawide-Field Imaging for Determining Severity of Diabetic Retinopathy. JAMA Ophthalmol. 2019 Jan 1;137(1):65-73. doi: 10.1001/jamaophthalmol.2018.4982. — View Citation
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Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of the modified Airlie House classification. ETDRS report number 10. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806. — View Citation
Hirano T, Imai A, Kasamatsu H, Kakihara S, Toriyama Y, Murata T. Assessment of diabetic retinopathy using two ultra-wide-field fundus imaging systems, the Clarus(R) and Optos systems. BMC Ophthalmol. 2018 Dec 20;18(1):332. doi: 10.1186/s12886-018-1011-z. — View Citation
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Matsui Y, Ichio A, Sugawara A, Uchiyama E, Suimon H, Matsubara H, Sugimoto M, Ikesugi K, Kondo M. Comparisons of Effective Fields of Two Ultra-Widefield Ophthalmoscopes, Optos 200Tx and Clarus 500. Biomed Res Int. 2019 Dec 5;2019:7436293. doi: 10.1155/2019/7436293. eCollection 2019. — View Citation
Price LD, Au S, Chong NV. Optomap ultrawide field imaging identifies additional retinal abnormalities in patients with diabetic retinopathy. Clin Ophthalmol. 2015 Mar 24;9:527-31. doi: 10.2147/OPTH.S79448. eCollection 2015. — View Citation
Rasmussen ML, Broe R, Frydkjaer-Olsen U, Olsen BS, Mortensen HB, Peto T, Grauslund J. Comparison between Early Treatment Diabetic Retinopathy Study 7-field retinal photos and non-mydriatic, mydriatic and mydriatic steered widefield scanning laser ophthalmoscopy for assessment of diabetic retinopathy. J Diabetes Complications. 2015 Jan-Feb;29(1):99-104. doi: 10.1016/j.jdiacomp.2014.08.009. Epub 2014 Aug 28. — View Citation
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Silva PS, Cavallerano JD, Haddad NM, Kwak H, Dyer KH, Omar AF, Shikari H, Aiello LM, Sun JK, Aiello LP. Peripheral Lesions Identified on Ultrawide Field Imaging Predict Increased Risk of Diabetic Retinopathy Progression over 4 Years. Ophthalmology. 2015 May;122(5):949-56. doi: 10.1016/j.ophtha.2015.01.008. Epub 2015 Feb 19. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ETDRS severity level according to the Early Treatment Diabetic Retinopathy Study - Diabetic Retinopathy Severity Scale (ETDRS-DRSS). | Compare DR severity level between the ETDRS 7-fields imaging and the wide-field imaging techniques: Clarus 500TM and OptosTM. The ETDRS - DRSS goes from level 10 - no presence of DR to level 75 - Severe proliferative DR | 12 months | |
Primary | One or more than 2-steps change on ETDRS - DRSS severity level | Compare ETDRS -DRSS between the two imaging techniques and evaluate the presence of 1 step or more than 2 steps difference between ETDRS 7-fields imaging and the wide-field imaging techniques: Clarus 500TM and OptosTM | 12 months | |
Primary | Peripheral DR lesions characterization | Investigate the peripheral area and analyze the presence, distribution, and severity of peripheral DR lesions, in wide-field images: Clarus 500TM and OptosTM.
Presence and distribution of lesions in the periphery will be evaluated as 1) Not observed; 2) predominantly observed outside ETDRS fields; 3) Uniformly distributed within and outside ETDRS fields. 4) Ungradable. Severity of the peripheral lesions will be evaluated using the same ETDRS-DRSS scale described above and will vary between level 35 and level 65. Also, it will then be compared with the ETDRS 7-field area and graded as less, equivalent or greater than the observed inside ETDRS 7-fields area. |
12 months | |
Secondary | Evaluation of Images quality in each imaging modality. | Images from each modality (7-fields, Clarus 500 and Optos TM) will be analysed according to 1) presence of artifacts like eyelashes, halos, eyelids, cataract opacities, etc; 2) Presence of unfocused areas 3) % of area occupied by those artifacts. | 12 months | |
Secondary | Evaluation of Patients satisfaction about each imagining modality. | To evaluate patient's experience and degree of satisfaction in each imaging modality, a questionnaire will be developed with qualitative and quantitative questions covering all aspects of the experience. | 12 months | |
Secondary | Correlate and analysed DR findings in each imaging technique with disease severity | To characterize the study population, demographic, and systemic characteristics, as well as visual function (BCVA), will be collected and analysed to correlate DR findings in each imaging technique with disease severity | 12 months |
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