Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201709002511161 Date of Approval: 10/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title OCT angiography in diabetics without retinopathy
Official scientific title OCT angiography microvascular changes in diabetics without diabetic retinopathy
Brief summary describing the background and objectives of the trial Aims : to analyse the retinal vasculature of diabetic eyes without clinical retinopathy in order to detect microvascular abnormalities, comparing them to that of healthy. Methods : a prospective, cross-sectional study including 40 patients. Twenty diabetics with no diabetic retinopathy (NDRG) and twenty non diabetic patients(the control groupe CG). Images were obtained using the AngioVue OCTA software of RTVUEXR spectral domain OCT device. We performe 3×3-mm and 6 ×6-mm scans centered at the fovea to evaluated the foveolar avascular zone (FAZ) size, a remodeling of the FAZ, microaneurysms , Vessel tortuosity and superficial vascular density.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied diabetes, diabetic retinopathy,Eye Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2017
Actual trial start date 01/08/2017
Anticipated date of last follow up 01/09/2017
Actual Last follow-up date 01/09/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group optical coherence tomography angiographyin diabetic patients without retinopathy 1 Images were obtained using the AngioVue OCTA software of RTVue XR spectral domain OCT device. We performed 3×3-mm and 6 ×6-mm scans centered at the fovea 20 Uncontrolled
Control Group optical coherence tomography angiography in non diabetic patients 1 Images were obtained using the AngioVue OCTA software of RTVue XR spectral domain OCT device. We performed 3×3-mm and 6 ×6-mm scans centered at the fovea 20 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
absence of diabetic retinopathy retinal vascular occlusive disease, hypertensive retinopathy, central serous chorioretinopathy, age-related macular degeneration, high myopia, vitreoretinal interface diseases, optic nerve diseases such as glaucoma and optic neuropathy, retinal photocoagulation intra ocular surgery 30 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/07/2017 ethic comitee of the FSI hospital
Ethics Committee Address
Street address City Postal code Country
rue taher ben achour la marsa 2070 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome presence of microvascular changes in OCTA of diabetic patients without retinopathy during the interpretation of the imaging
Secondary Outcome no secondary outcome no secondary outcome
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FSI HOSPITAL RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
FSI hospital RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FSI hospital RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Houda Lajmi RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
Hmaied Wassim RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
Amin Zahaf RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
Zied Chelly RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
Lamia El Fekih RUE TAHER BEN ACHOUR LA MARSA 2070 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Houda Lajmi houda.lajmi@gmail.com +21622529480 rue taher ben achour
City Postal code Country Position/Affiliation
la marsa 2070 Tunisia FSI hospital
Role Name Email Phone Street address
Public Enquiries Wassim Hmaied hmaied.wassim@yahoo.fr +21671505503 RUE TAHER BEN ACHOUR
City Postal code Country Position/Affiliation
LA MARSA 2070 Tunisia FSI HOSPITAL
Role Name Email Phone Street address
Scientific Enquiries houda lajmi houda.lajmi@gmail.com +21622529480 RUE TAHER BEN ACHOUR
City Postal code Country Position/Affiliation
LA MARSA 2070 Tunisia FSI HOSPITAL
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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