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The Role of Anterior Segment Optical Coherence Tomography (AS-OCT) in the Diagnosis of Ocular Surface Lesions

ETH-20260407-0148 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
Needs Revision
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-20260407-0148
رقم الطلب
Request Number
ETH-20260407-0148
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
The Role of Anterior Segment Optical Coherence Tomography (AS-OCT) in the Diagnosis of Ocular Surface Lesions
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
This study investigates the role of Anterior Segment Optical Coherence Tomography (AS-OCT) as a non-invasive tool for diagnosing ocular surface lesions, such as pterygium, conjunctival nevus, and ocular surface squamous neoplasia (OSSN), at Al-Jawarih Eye Hospital in Sudan. Traditionally, diagnosis relies on clinical examination and biopsy, but biopsy is invasive and may cause complications. AS-OCT offers high-resolution imaging of the العين surface and may help differentiate between benign and malignant lesions without surgery. The study is a prospective observational design involving 50–100 patients over 12–24 months. Each patient will undergo clinical examination, AS-OCT imaging, and histopathological analysis (when indicated), with histopathology serving as the gold standard for comparison. The main objective is to evaluate the diagnostic accuracy of AS-OCT, including its sensitivity, specificity, and ability to distinguish benign from malignant lesions. Data will be analyzed statistically to assess agreement between AS-OCT and biopsy results. The study expects that AS-OCT will show characteristic patterns for different lesions, achieve high sensitivity for detecting malignancies, and potentially reduce the need for invasive biopsies. Overall, this research aims to promote safer, non-invasive diagnostic methods, improve early detection of serious conditions, and support better clinical decision-making, despite limitations such as small sample size and limited access to AS-OCT technology.

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

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

معلومات الدراسة / Study Information

أبحاث طبية / Medical Research

messages.degree_medical_research - messages.degree_medical_research

21,000.00 SDG

This study investigates the role of Anterior Segment Optical Coherence Tomography (AS-OCT) as a non-invasive tool for diagnosing ocular surface lesions, such as pterygium, conjunctival nevus, and ocular surface squamous neoplasia (OSSN), at Al-Jawarih Eye Hospital in Sudan. Traditionally, diagnosis relies on clinical examination and biopsy, but biopsy is invasive and may cause complications. AS-OCT offers high-resolution imaging of the العين surface and may help differentiate between benign and malignant lesions without surgery. The study is a prospective observational design involving 50–100 patients over 12–24 months. Each patient will undergo clinical examination, AS-OCT imaging, and histopathological analysis (when indicated), with histopathology serving as the gold standard for comparison. The main objective is to evaluate the diagnostic accuracy of AS-OCT, including its sensitivity, specificity, and ability to distinguish benign from malignant lesions. Data will be analyzed statistically to assess agreement between AS-OCT and biopsy results. The study expects that AS-OCT will show characteristic patterns for different lesions, achieve high sensitivity for detecting malignancies, and potentially reduce the need for invasive biopsies. Overall, this research aims to promote safer, non-invasive diagnostic methods, improve early detection of serious conditions, and support better clinical decision-making, despite limitations such as small sample size and limited access to AS-OCT technology.

Apr 10, 2026 - Dec 10, 2026

الاعتبارات الأخلاقية / Ethical Considerations

Verbal

مخاطر متوسطة - Medium 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