Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
NCT ID: NCT00763802
Last Updated: 2014-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2007-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MNPDR
Type 2 diabetic patients with Mild non-prolipherative retinopathy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age between 35 and 75 years.
* Mild non-prolipherative retinopathy (based on ETDRS criteria)
* Best Corrected Visual acuity \>20 /25
* Refraction with a spherical equivalent less than 5 Dp.
* Inform consent
Exclusion Criteria
* Glaucoma
* Vitreous syneresis or posterior vitreous detachment
* Other retinal vascular disease
* Recent intraocular surgery
* Previous laser therapy
* Dilatation of the pupil \< 5 mm
35 Years
75 Years
ALL
No
Sponsors
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Fundação para a Ciência e a Tecnologia
OTHER
Association for Innovation and Biomedical Research on Light and Image
OTHER
Responsible Party
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Principal Investigators
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José G Cunha-Vaz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Association for Innovation and Biomedical Research on Light and Image
Locations
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AIBILI
Coimbra, Coimbra District, Portugal
Countries
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References
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Cunha-Vaz J, Bernardes R. Nonproliferative retinopathy in diabetes type 2. Initial stages and characterization of phenotypes. Prog Retin Eye Res. 2005 May;24(3):355-77. doi: 10.1016/j.preteyeres.2004.07.004. Epub 2004 Dec 16.
Lobo CL, Bernardes RC, Figueira JP, de Abreu JR, Cunha-Vaz JG. Three-year follow-up study of blood-retinal barrier and retinal thickness alterations in patients with type 2 diabetes mellitus and mild nonproliferative diabetic retinopathy. Arch Ophthalmol. 2004 Feb;122(2):211-7. doi: 10.1001/archopht.122.2.211.
Hayreh SS. Diabetic papillopathy and nonarteritic anterior ischemic optic neuropathy. Surv Ophthalmol. 2002 Nov-Dec;47(6):600-2; author reply 602. doi: 10.1016/s0039-6257(02)00358-2. No abstract available.
Pires I, Bernardes RC, Lobo CL, Soares MA, Cunha-Vaz JG. Retinal thickness in eyes with mild nonproliferative retinopathy in patients with type 2 diabetes mellitus: comparison of measurements obtained by retinal thickness analysis and optical coherence tomography. Arch Ophthalmol. 2002 Oct;120(10):1301-6. doi: 10.1001/archopht.120.10.1301.
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, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.
Pires I, Santos AR, Nunes S, Lobo C, Cunha-Vaz J. Subclinical macular edema as a predictor of progression to clinically significant macular edema in type 2 diabetes. Ophthalmologica. 2013;230(4):201-6. doi: 10.1159/000354550. Epub 2013 Sep 25.
Nunes S, Ribeiro L, Lobo C, Cunha-Vaz J. Three different phenotypes of mild nonproliferative diabetic retinopathy with different risks for development of clinically significant macular edema. Invest Ophthalmol Vis Sci. 2013 Jul 10;54(7):4595-604. doi: 10.1167/iovs.13-11895.
Pires I, Santos AR, Nunes S, Lobo C. Macular thickness measured by stratus optical coherence tomography in patients with diabetes type 2 and mild nonproliferative retinopathy without clinical evidence of macular edema. Ophthalmologica. 2013;229(4):181-6. doi: 10.1159/000350593. Epub 2013 Apr 24.
Ribeiro ML, Nunes SG, Cunha-Vaz JG. Microaneurysm turnover at the macula predicts risk of development of clinically significant macular edema in persons with mild nonproliferative diabetic retinopathy. Diabetes Care. 2013 May;36(5):1254-9. doi: 10.2337/dc12-1491. Epub 2012 Nov 30.
Related Links
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Related Info
Other Identifiers
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PTDC/SAU-OSM/72635/2006
Identifier Type: -
Identifier Source: org_study_id
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