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Effect of Intravitreal Injection on Central Macular Thickness and Visual Acuity in Diabetic Patients

ETH-20260407-0145 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-20260407-0145
رقم الطلب
Request Number
ETH-20260407-0145
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
-
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
Effect of Intravitreal Injection on Central Macular Thickness and Visual Acuity in Diabetic Patients
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:** Effect of Intravitreal Injection on Central Macular Thickness and Visual Acuity in Diabetic Patients ### **Background** Diabetic macular edema (DME) is a leading cause of visual impairment in diabetic patients, resulting from retinal thickening due to increased vascular permeability. Optical Coherence Tomography (OCT) allows precise measurement of central macular thickness (CMT). Intravitreal injections of anti-VEGF agents or corticosteroids are commonly used to reduce macular edema and improve vision, though patient responses vary. Local data on treatment outcomes in Sudan are limited. ### **Problem** Despite the increasing use of intravitreal injections for DME, there is a lack of local evidence on their effectiveness in reducing CMT and improving visual acuity among Sudanese patients. ### **Objectives** * **General:** Assess the effect of intravitreal injections on CMT and visual acuity. * **Specific:** * Measure CMT changes post-injection * Evaluate changes in best-corrected visual acuity (BCVA) * Correlate CMT reduction with visual improvement * Assess short-term outcomes at 1 and 3 months * Compare effects of different drugs ### **Research Questions** 1. Do intravitreal injections reduce central macular thickness? 2. Do they improve visual acuity in diabetic patients? 3. Is there a correlation between CMT reduction and vision improvement? ### **Methodology** * **Design:** Prospective hospital-based interventional study * **Location:** Aljawareh Hospital * **Population:** Diabetic patients ≥18 years with OCT-confirmed DME * **Exclusions:** Recent intraocular surgery, other retinal diseases * **Sampling:** Consecutive sampling * **Data Collection:** Baseline demographics, diabetes duration, HbA1c, visual acuity, OCT CMT. Intervention: intravitreal injection. Follow-up at 1 and 3 months with repeated visual acuity and OCT measurements. * **Analysis:** SPSS; paired t-tests, correlation analysis; significance at p < 0.05 ### **Expected Outcomes** * Significant reduction in central macular thickness * Improvement in visual acuity * Positive correlation between anatomical (CMT) and functional (vision) outcomes ### **Ethics** * Approval from Ministry of Health, Northern State, Sudan * Informed consent and confidentiality ensured ### **Limitations** * Short follow-up * Small sample size * No control group ### **Timeline** * Proposal: 1 week * Data collection: 3–6 months * Data analysis: 1 month * Report writing: 1 month ### **Budget Considerations** * OCT scans * Injection materials * Data collection tools * Transport/logistics

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:** Effect of Intravitreal Injection on Central Macular Thickness and Visual Acuity in Diabetic Patients ### **Background** Diabetic macular edema (DME) is a leading cause of visual impairment in diabetic patients, resulting from retinal thickening due to increased vascular permeability. Optical Coherence Tomography (OCT) allows precise measurement of central macular thickness (CMT). Intravitreal injections of anti-VEGF agents or corticosteroids are commonly used to reduce macular edema and improve vision, though patient responses vary. Local data on treatment outcomes in Sudan are limited. ### **Problem** Despite the increasing use of intravitreal injections for DME, there is a lack of local evidence on their effectiveness in reducing CMT and improving visual acuity among Sudanese patients. ### **Objectives** * **General:** Assess the effect of intravitreal injections on CMT and visual acuity. * **Specific:** * Measure CMT changes post-injection * Evaluate changes in best-corrected visual acuity (BCVA) * Correlate CMT reduction with visual improvement * Assess short-term outcomes at 1 and 3 months * Compare effects of different drugs ### **Research Questions** 1. Do intravitreal injections reduce central macular thickness? 2. Do they improve visual acuity in diabetic patients? 3. Is there a correlation between CMT reduction and vision improvement? ### **Methodology** * **Design:** Prospective hospital-based interventional study * **Location:** Aljawareh Hospital * **Population:** Diabetic patients ≥18 years with OCT-confirmed DME * **Exclusions:** Recent intraocular surgery, other retinal diseases * **Sampling:** Consecutive sampling * **Data Collection:** Baseline demographics, diabetes duration, HbA1c, visual acuity, OCT CMT. Intervention: intravitreal injection. Follow-up at 1 and 3 months with repeated visual acuity and OCT measurements. * **Analysis:** SPSS; paired t-tests, correlation analysis; significance at p < 0.05 ### **Expected Outcomes** * Significant reduction in central macular thickness * Improvement in visual acuity * Positive correlation between anatomical (CMT) and functional (vision) outcomes ### **Ethics** * Approval from Ministry of Health, Northern State, Sudan * Informed consent and confidentiality ensured ### **Limitations** * Short follow-up * Small sample size * No control group ### **Timeline** * Proposal: 1 week * Data collection: 3–6 months * Data analysis: 1 month * Report writing: 1 month ### **Budget Considerations** * OCT scans * Injection materials * Data collection tools * Transport/logistics

Apr 10, 2026 - Sep 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