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Accuracy of B-Scan Ultrasonography in the Diagnosis of Posterior Segment Pathologies in Patients Undergoing Pars Plana Vitrectomy (PPV)

ETH-20260407-0143 تاريخ التقديم: Apr 07, 2026 / Submitted: Apr 07, 2026
قيمة الرسوم / Payment Amount
21,000.00 SDG
نوع البحث / Research Type
أبحاث طبية / Medical Research
فترة الدراسة / Study Period
Apr 10, 2026 - Dec 10, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20260407-0143
رقم الطلب
Request Number
ETH-20260407-0143
تاريخ تقديم الطلب
Date of Submission
2026-04-07

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Marouf Mohamed Marouf Ali
2. الجهة التي ينتمي إليها
Affiliation Type
مؤسسة / Institution
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
marouf502@gmail.com
5. رقم الهاتف
Phone Number
00249906214085
المشرف / Supervisor
الاسم الكامل / Full Name
-
البريد الإلكتروني / Email
-
الوظيفة / اللقب العلمي / Job Title
-
رقم الهاتف / Phone
-
القسم / المؤسسة / Department
-

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Accuracy of B-Scan Ultrasonography in the Diagnosis of Posterior Segment Pathologies in Patients Undergoing Pars Plana Vitrectomy (PPV)
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☐بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☐ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☑أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
**Title:** Accuracy of B-Scan Ultrasonography in the Diagnosis of Posterior Segment Pathologies in Patients Undergoing Pars Plana Vitrectomy (PPV) **Background:** Visualization of the posterior segment of the eye can be limited by conditions like dense cataract, vitreous hemorrhage, corneal opacity, or hyphema. B-scan ultrasonography offers real-time imaging of intraocular structures and helps detect retinal detachment (RD), vitreous hemorrhage (VH), posterior vitreous detachment (PVD), intraocular tumors, and choroidal detachment. PPV provides direct intraoperative visualization and is the gold standard for diagnosis. Evaluating B-scan accuracy is crucial for improving diagnostic confidence, guiding surgery, and avoiding unnecessary interventions. **Problem:** B-scan ultrasonography is widely used, especially in resource-limited settings, but local data comparing its accuracy with intraoperative findings is limited. **Objectives:** * **General:** Assess the accuracy of B-scan ultrasonography for posterior segment pathologies in patients undergoing PPV. * **Specific:** Determine sensitivity, specificity, PPV, NPV; compare preoperative B-scan with intraoperative findings; evaluate accuracy for specific conditions like RD, VH, and choroidal detachment. **Research Questions:** 1. How accurate is B-scan ultrasonography for posterior segment pathologies? 2. What are its sensitivity and specificity compared to intraoperative findings? 3. Does accuracy vary by pathology type? **Methodology:** * **Design:** Prospective observational study * **Location:** Al Jawareh Eye Hospital, Dongola, Sudan * **Population:** Patients undergoing PPV with preoperative B-scan * **Inclusion:** Scheduled for PPV, media opacity preventing fundus visualization * **Exclusion:** Incomplete records, poor-quality ultrasound images * **Sample:** All eligible patients during study period (convenience sampling) * **Data:** Demographics, clinical data, B-scan findings, intraoperative findings * **Outcome Measures:** Sensitivity, specificity, PPV, NPV of B-scan ultrasonography * **Analysis:** SPSS software; cross-tabulation; Kappa statistic; significance at p<0.05 **Ethics:** Approved by the institutional review board; informed consent obtained; patient confidentiality maintained. **Expected Results:** * High sensitivity of B-scan for RD and VH * Moderate specificity for some conditions * Strong agreement between ultrasound and intraoperative findings * Accuracy may vary depending on pathology type **Limitations:** Operator dependency, small sample size, selection bias, limited generalizability. **Timeline:** 6–9 months, including proposal approval, data collection, analysis, and report writing.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☐مكتوبة / Written
☑شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☐إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
collect only necessary data, anonymize/pseudonymize it, store and transmit securely, limit access, get consent, de-identify results, and follow laws/regulations.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
-
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
Access to new treatments or interventions Contribution to scientific knowledge and society Personal health insights or screenings Learning about the condition or research process Feeling empowered by contributing to change Possible financial or material compensation
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Marouf Mohamed Marouf Ali
التوقيع / Signature
_______________________
التاريخ / Date
2026-04-07

معلومات الباحث / Researcher Information

M

Marouf Mohamed Marouf Ali

marouf502@gmail.com

00249906214085

Al-Jawarih Eye Hospital, Dongola, North state

اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted

Dongola, behaind Ansar Alsunah Mosque

معلومات الدراسة / Study Information

أبحاث طبية / Medical Research

messages.degree_medical_research - messages.degree_medical_research

21,000.00 SDG

**Title:** Accuracy of B-Scan Ultrasonography in the Diagnosis of Posterior Segment Pathologies in Patients Undergoing Pars Plana Vitrectomy (PPV) **Background:** Visualization of the posterior segment of the eye can be limited by conditions like dense cataract, vitreous hemorrhage, corneal opacity, or hyphema. B-scan ultrasonography offers real-time imaging of intraocular structures and helps detect retinal detachment (RD), vitreous hemorrhage (VH), posterior vitreous detachment (PVD), intraocular tumors, and choroidal detachment. PPV provides direct intraoperative visualization and is the gold standard for diagnosis. Evaluating B-scan accuracy is crucial for improving diagnostic confidence, guiding surgery, and avoiding unnecessary interventions. **Problem:** B-scan ultrasonography is widely used, especially in resource-limited settings, but local data comparing its accuracy with intraoperative findings is limited. **Objectives:** * **General:** Assess the accuracy of B-scan ultrasonography for posterior segment pathologies in patients undergoing PPV. * **Specific:** Determine sensitivity, specificity, PPV, NPV; compare preoperative B-scan with intraoperative findings; evaluate accuracy for specific conditions like RD, VH, and choroidal detachment. **Research Questions:** 1. How accurate is B-scan ultrasonography for posterior segment pathologies? 2. What are its sensitivity and specificity compared to intraoperative findings? 3. Does accuracy vary by pathology type? **Methodology:** * **Design:** Prospective observational study * **Location:** Al Jawareh Eye Hospital, Dongola, Sudan * **Population:** Patients undergoing PPV with preoperative B-scan * **Inclusion:** Scheduled for PPV, media opacity preventing fundus visualization * **Exclusion:** Incomplete records, poor-quality ultrasound images * **Sample:** All eligible patients during study period (convenience sampling) * **Data:** Demographics, clinical data, B-scan findings, intraoperative findings * **Outcome Measures:** Sensitivity, specificity, PPV, NPV of B-scan ultrasonography * **Analysis:** SPSS software; cross-tabulation; Kappa statistic; significance at p<0.05 **Ethics:** Approved by the institutional review board; informed consent obtained; patient confidentiality maintained. **Expected Results:** * High sensitivity of B-scan for RD and VH * Moderate specificity for some conditions * Strong agreement between ultrasound and intraoperative findings * Accuracy may vary depending on pathology type **Limitations:** Operator dependency, small sample size, selection bias, limited generalizability. **Timeline:** 6–9 months, including proposal approval, data collection, analysis, and report writing.

Apr 10, 2026 - Dec 10, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Verbal

مخاطر منخفضة - Low Risk

collect only necessary data, anonymize/pseudonymize it, store and transmit securely, limit access, get consent, de-identify results, and follow laws/regulations.

Access to new treatments or interventions Contribution to scientific knowledge and society Personal health insights or screenings Learning about the condition or research process Feeling empowered by contributing to change Possible financial or material compensation

Elderly