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The purpose of this study is to prospectively evaluate the value of Optical coherence tomography angiography (OCT-A) for the of detection of suspected retinal complications With Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection
During 3 months duration ( the treatment course duration) , Optical coherence tomography angiography (OCT-A) will be performed to 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C before and after receiving dual-therapy planning (Daclatasvir - Sofosbuvir (Sovaldi)) , normal renal functions And Rheumatoid factor tests , will undergo a comprehensive ophthalmic examination including:
Recent Optical coherence tomography angiography (OCT-A) will be performed to all patients before Treatment Administration.
Examination will be performed using "Optovue AngioVue®" "Optovue, Inc., Fremont, CA", which uses split-spectrum amplitude-decorrelation angiography algorithm, which minimizes motion noise. This system also allows quantitative analysis, since it provides numerical data about flow area and flow density maps.
The patient will be examined before and after finishing the treatment course
* Optical coherence tomography angiography (OCT-A) image acquisition OCT-A will be done for all patients who are instructed to focus on a fixation target. OCTA images are obtained using the "RTVue XR Avanti (AngioVue; Optovue Inc, Fremont, California, USA)" machine and the incorporated "AngioVue OCT-A" system. Algorithm used is Split-Spectrum Amplitude Decorrelation Algorithm (SSADA). The scans which will be included in the study are of high signal strength more than 0.7 and they will be carefully inspected for motion artifacts. Automatic segmentation of intraretinal layers will be done using the automated software of the machine (version 2016.2.0; Optovue Inc). Angio-retina scan sizes in this study will be 6 X 6 mm for all eyes. Assessment of the macular vessel density will be done for superficial vascular layer, capillary plexus, deep capillary plexus and all retinal plexuses). Assessment of the foveal avascular zone on both superficial vascular layer (SVL) and deep capillary plexuses (DCP); including its size, perimeter and circularity (regularity) index. Circularity index is a measure of compactness of a shape relative to a circle. The circularity index of a circle is 1.0. Thus, a ratio closer to 0 indicates an irregular shape, and that closer to 1.0 indicates a circular shape.
All results will be in numerical values (percentage) to compare retinal vascularity before and after using the drug. Best corrected visual acuity (in values from o.o5 to 1.0) , dryness (in seconds) will be also measured before and after drug administration and it will be compared .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sovaldi group | patients with a documented diagnosis of chronic hepatitis C , normal renal functions And Rheumatoid factor tests (to exclude Purtscher like retinopathy as a rare presentation of cryoglobuinemia which considered one of extra hepatic manifestations of HCV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography angiography | Device | Recent Optical coherence tomography angiography "OCT-A" will be performed to all patients before Treatment Administration.
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment percentage of change in macular vessels density using OCTA | Evaluate the suspected retinal vascular complications With Sofosbuvir (Sovaldi) ) in Patients With Hepatitis C Virus Infection, All results will be in numerical values (percentage) to compare retinal vascularity before and after using the drug.. | 3 months |
| visual acuity changes with Sofosbuvir | Comparing best corrected visual acuity (in values from o.o5 to 1.0) before and after drug administration . | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| amount of ocular dryness with Sofosbuvir using tear up breaking test | Measuring amount of ocular dryness using Tear-up breaking test, dryness will be evaluated in seconds before and after drug administration and it will be compared . | 3 months |
| Role of Optical coherence tomography angiography (OCTA) in detection early signs retinopathy depending on changes in vascular density |
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Inclusion Criteria:
Exclusion Criteria:
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Convenience sample 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C
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| Name | Affiliation | Role |
|---|---|---|
| Hany E Elmekewy, MD | Cairo University | Principal Investigator |
| Magada S Abdelaziz, MD | Cairo University | Principal Investigator |
| Yomna A Abdelwahab, MD | Cairo University | Principal Investigator |
| Mai I Mehrez, MD | National Hepatology & Tropical Medicine Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University - Kasr Alainy | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27162457 | Background | Chebil A, Mammouri R, Abdallah MB, El Matri L. Purtscher-like Retinopathy as a Rare Presentation of Cryoglobulinemia. Middle East Afr J Ophthalmol. 2016 Apr-Jun;23(2):219-21. doi: 10.4103/0974-9233.177409. | |
| 26764884 | Background | Salman AG. Ocular Surface Changes With Sofosbuvir in Egyptian Patients With Hepatitis C Virus Infection. Cornea. 2016 Mar;35(3):323-8. doi: 10.1097/ICO.0000000000000736. |
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All required non private data
30 November 2019
upon request of Any qualified and specialized Doctor or medical journal
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2019 | Nov 6, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 15, 2019 | Nov 6, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
|
| Sofosbuvir (Sovaldi) | Drug | Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C , here it's used with Daclatasvir for 3 months |
|
|
Confirm the advantages of Optical coherence tomography angiography (OCT - A) in detection early signs retinopathy depending on changes in vascular density (evaluated as a percentage) |
| 3 months |
| amount of ocular dryness with Sofosbuvir using Schirmer's | Measuring amount of ocular dryness using Tear-up breaking test, dryness will be evaluated in millimeters of wetness of schirmer's strips before and after drug administration and it will be compared . | 3 months |
| 29260058 | Background | Manoharan N, Subramanian PS. A case of non-arteritic anterior ischemic optic neuropathy after completion of Harvoni therapy. Am J Ophthalmol Case Rep. 2017 Mar 8;6:55-57. doi: 10.1016/j.ajoc.2017.03.002. eCollection 2017 Jun. |
| 27610281 | Background | Chin Loy K, Galaydh F, Shaikh S. Correction: Retinopathy and Uveitis Associated with Sofosbuvir Therapy for Chronic Hepatitis C Infection. Cureus. 2016 Jul 14;8(7):c3. doi: 10.7759/cureus.c3. |
| 23607594 | Background | Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |