Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures
NCT ID: NCT01145599
Last Updated: 2015-02-11
Study Results
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Basic Information
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COMPLETED
374 participants
OBSERVATIONAL
2010-09-30
Brief Summary
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Detailed Description
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* Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and
* Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Type-2 diabetes, NPDR
Type-2 diabetic patients with NPDR.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Age between 35 and 75 years
3. Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
4. Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
5. Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32)
6. Refraction with a spherical equivalent less than 5 Dp
7. Informed consent
Exclusion Criteria
2. Glaucoma
3. Any eye surgery within a period of 6-months
4. Other retinal vascular disease
5. Previous laser therapy
6. Dilatation of the pupil \< 5 mm
35 Years
75 Years
ALL
No
Sponsors
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European Vision Institute Clinical Research Network
NETWORK
Responsible Party
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Principal Investigators
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José Cunha-Vaz, MD PhD
Role: STUDY_CHAIR
Association for Innovation and Biomedical Research on Light and Image
Locations
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Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Coimbra District, Portugal
Countries
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References
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Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.
Cunha-Vaz J, Santos T, Ribeiro L, Alves D, Marques I, Goldberg M. OCT-Leakage: A New Method to Identify and Locate Abnormal Fluid Accumulation in Diabetic Retinal Edema. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6776-6783. doi: 10.1167/iovs.16-19999.
Ribeiro L, Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Neves C, Cunha-Vaz J; Evicr Net Study Group. Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2. Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708.
Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Bandello F, Cunha-Vaz J; for EVICR.net. One-year progression of diabetic subclinical macular edema in eyes with mild nonproliferative diabetic retinopathy: location of the increase in retinal thickness. Ophthalmic Res. 2015;54(3):118-23. doi: 10.1159/000438793. Epub 2015 Aug 21.
Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets RM, Coriat C, Wiedemann P, Agoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Cunha-Vaz J; EVICR.net. Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2. Ophthalmic Res. 2015;54(3):112-7. doi: 10.1159/000438792. Epub 2015 Aug 21.
Other Identifiers
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ECR-RET-2010-02
Identifier Type: -
Identifier Source: org_study_id
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