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Central Macular Thickness Before and After Phacoemulsification Among Diabetic Patients

ETH-20260407-0146 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-20260407-0146
رقم الطلب
Request Number
ETH-20260407-0146
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
Central Macular Thickness Before and After Phacoemulsification Among 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:** Central Macular Thickness Before and After Phacoemulsification Among Diabetic Patients ### **Background** Diabetes mellitus increases the risk of ocular complications such as diabetic retinopathy, diabetic macular edema (DME), and earlier cataract formation. Phacoemulsification is the most common cataract surgery but can trigger postoperative inflammation, potentially increasing central macular thickness (CMT) and worsening DME. Optical Coherence Tomography (OCT) provides a non-invasive, accurate method to measure CMT and monitor subtle changes before and after surgery. Understanding these changes is key to predicting visual outcomes, identifying high-risk patients, and improving perioperative management. ### **Problem** There is limited local data on how phacoemulsification affects CMT and visual outcomes in Sudanese diabetic patients. ### **Objectives** * **General:** Evaluate CMT changes before and after phacoemulsification. * **Specific:** * Measure preoperative CMT using OCT * Assess postoperative CMT at 1 and 3 months * Evaluate changes in visual acuity (VA) * Identify risk factors associated with increased postoperative CMT ### **Methodology** * **Design:** Prospective hospital-based observational study * **Location:** Aljawareh Eye Hospital, Dongola, Sudan * **Population:** Diabetic patients ≥18 years scheduled for phacoemulsification * **Exclusions:** Pre-existing macular edema, prior intraocular surgery, other retinal diseases, complicated surgeries * **Sampling:** Convenience sampling * **Data Collection:** Preoperative and postoperative (1 and 3 months) demographics, duration of diabetes, HbA1c, visual acuity, OCT CMT * **Analysis:** SPSS; descriptive statistics, paired t-tests (pre vs post CMT), correlation (CMT vs VA), regression for risk factors; significance at p < 0.05 ### **Expected Results** * Mild postoperative increase in CMT * Possible subclinical macular edema in some patients * Overall improvement in visual acuity despite CMT changes * Greater CMT changes in patients with longer diabetes duration ### **Ethics** * Approval from Ministry of Health, Northern State * Oral consent from participants, confidentiality maintained, no added risk ### **Limitations** * Short follow-up * Lack of control group (non-diabetic patients) ### **Timeline** * Proposal approval: 1 week * Data collection: 3–6 months * Data analysis: 1 month * Report writing: 1 month

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:** Central Macular Thickness Before and After Phacoemulsification Among Diabetic Patients ### **Background** Diabetes mellitus increases the risk of ocular complications such as diabetic retinopathy, diabetic macular edema (DME), and earlier cataract formation. Phacoemulsification is the most common cataract surgery but can trigger postoperative inflammation, potentially increasing central macular thickness (CMT) and worsening DME. Optical Coherence Tomography (OCT) provides a non-invasive, accurate method to measure CMT and monitor subtle changes before and after surgery. Understanding these changes is key to predicting visual outcomes, identifying high-risk patients, and improving perioperative management. ### **Problem** There is limited local data on how phacoemulsification affects CMT and visual outcomes in Sudanese diabetic patients. ### **Objectives** * **General:** Evaluate CMT changes before and after phacoemulsification. * **Specific:** * Measure preoperative CMT using OCT * Assess postoperative CMT at 1 and 3 months * Evaluate changes in visual acuity (VA) * Identify risk factors associated with increased postoperative CMT ### **Methodology** * **Design:** Prospective hospital-based observational study * **Location:** Aljawareh Eye Hospital, Dongola, Sudan * **Population:** Diabetic patients ≥18 years scheduled for phacoemulsification * **Exclusions:** Pre-existing macular edema, prior intraocular surgery, other retinal diseases, complicated surgeries * **Sampling:** Convenience sampling * **Data Collection:** Preoperative and postoperative (1 and 3 months) demographics, duration of diabetes, HbA1c, visual acuity, OCT CMT * **Analysis:** SPSS; descriptive statistics, paired t-tests (pre vs post CMT), correlation (CMT vs VA), regression for risk factors; significance at p < 0.05 ### **Expected Results** * Mild postoperative increase in CMT * Possible subclinical macular edema in some patients * Overall improvement in visual acuity despite CMT changes * Greater CMT changes in patients with longer diabetes duration ### **Ethics** * Approval from Ministry of Health, Northern State * Oral consent from participants, confidentiality maintained, no added risk ### **Limitations** * Short follow-up * Lack of control group (non-diabetic patients) ### **Timeline** * Proposal approval: 1 week * Data collection: 3–6 months * Data analysis: 1 month * Report writing: 1 month

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