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Indications and Outcomes of Pars Plana Vitrectomy (PPV) in a Tertiary Eye Center

ETH-20260407-0147 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 - Sep 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
---
Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
---
رقم التسلسل
Serial Number
SER-20260407-0147
رقم الطلب
Request Number
ETH-20260407-0147
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
Indications and Outcomes of Pars Plana Vitrectomy (PPV) in a Tertiary Eye Center
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:** Indications and Outcomes of Pars Plana Vitrectomy (PPV) in a Tertiary Eye Center ### **Background** Pars plana vitrectomy (PPV) is a microsurgical procedure widely used to treat vitreoretinal diseases such as vitreous hemorrhage, retinal detachment, epiretinal membrane, macular hole, and diabetic retinopathy complications. Advances in surgical techniques and instrumentation have improved outcomes. However, surgical success depends on indications, disease duration, patient characteristics, and surgeon expertise. Local data on PPV indications and outcomes in Sudan are limited. ### **Problem** There is insufficient local information on the common indications, visual outcomes, anatomical success, and complication rates for PPV in tertiary eye centers, which is essential for planning, optimizing care, and resource allocation. ### **Objectives** * **General:** Evaluate indications and outcomes of PPV at Aljawareh Eye Hospital. * **Specific:** * Identify the most common indications for PPV * Assess postoperative visual acuity outcomes * Evaluate anatomical success rates (retinal reattachment, media clarity) * Identify intraoperative and postoperative complications ### **Methodology** * **Design:** Hospital-based prospective descriptive study * **Location:** Aljawareh Eye Hospital, Dongola, Sudan * **Population:** All patients undergoing PPV during the study period * **Exclusions:** Incomplete records, lost to follow-up * **Sampling:** Total coverage of all eligible cases * **Data Collection:** Patient records, surgical logs, OCT/imaging; variables include demographics, indications, duration of symptoms, surgical details (tamponade, combined procedures), pre- and postoperative VA, anatomical outcomes, and complications (cataract, elevated IOP, endophthalmitis, re-detachment) * **Analysis:** SPSS 26.0; descriptive statistics (frequencies, mean ± SD), paired t-tests for VA, chi-square and regression for predictors; significance p < 0.05 ### **Expected Outcomes** * Vitreous hemorrhage and retinal detachment as the most common indications * Significant improvement in visual acuity * High anatomical success rates * Acceptable complication rates comparable to international standards ### **Ethics** * Approval from Ministry of Health, Northern State, Sudan * Confidentiality of patient data; informed consent for prospective cases ### **Limitations** * Short follow-up * Missing data or loss to follow-up ### **Timeline** * Proposal approval: 1 month * Data collection: 2–4 months * Data analysis: 1 month * Report writing: 1 month ### **Budget** * Data collection materials * Printing and documentation * Statistical software

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

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:** Indications and Outcomes of Pars Plana Vitrectomy (PPV) in a Tertiary Eye Center ### **Background** Pars plana vitrectomy (PPV) is a microsurgical procedure widely used to treat vitreoretinal diseases such as vitreous hemorrhage, retinal detachment, epiretinal membrane, macular hole, and diabetic retinopathy complications. Advances in surgical techniques and instrumentation have improved outcomes. However, surgical success depends on indications, disease duration, patient characteristics, and surgeon expertise. Local data on PPV indications and outcomes in Sudan are limited. ### **Problem** There is insufficient local information on the common indications, visual outcomes, anatomical success, and complication rates for PPV in tertiary eye centers, which is essential for planning, optimizing care, and resource allocation. ### **Objectives** * **General:** Evaluate indications and outcomes of PPV at Aljawareh Eye Hospital. * **Specific:** * Identify the most common indications for PPV * Assess postoperative visual acuity outcomes * Evaluate anatomical success rates (retinal reattachment, media clarity) * Identify intraoperative and postoperative complications ### **Methodology** * **Design:** Hospital-based prospective descriptive study * **Location:** Aljawareh Eye Hospital, Dongola, Sudan * **Population:** All patients undergoing PPV during the study period * **Exclusions:** Incomplete records, lost to follow-up * **Sampling:** Total coverage of all eligible cases * **Data Collection:** Patient records, surgical logs, OCT/imaging; variables include demographics, indications, duration of symptoms, surgical details (tamponade, combined procedures), pre- and postoperative VA, anatomical outcomes, and complications (cataract, elevated IOP, endophthalmitis, re-detachment) * **Analysis:** SPSS 26.0; descriptive statistics (frequencies, mean ± SD), paired t-tests for VA, chi-square and regression for predictors; significance p < 0.05 ### **Expected Outcomes** * Vitreous hemorrhage and retinal detachment as the most common indications * Significant improvement in visual acuity * High anatomical success rates * Acceptable complication rates comparable to international standards ### **Ethics** * Approval from Ministry of Health, Northern State, Sudan * Confidentiality of patient data; informed consent for prospective cases ### **Limitations** * Short follow-up * Missing data or loss to follow-up ### **Timeline** * Proposal approval: 1 month * Data collection: 2–4 months * Data analysis: 1 month * Report writing: 1 month ### **Budget** * Data collection materials * Printing and documentation * Statistical software

Apr 10, 2026 - Sep 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