Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202510501881152 Date of Registration: 14/10/2025
Trial Status: Incomplete - The data on this application is incomplete
TRIAL DESCRIPTION
Public title Outcomes of posttraumatic Orbital reconstruction
Official scientific title Outcomes of posttraumatic Orbital reconstruction
Brief summary describing the background and objectives of the trial This study aimed to assess the outcomes of posttraumatic orbital reconstruction using different materials, the timing of intervention, adequate positioning of the material, and preoperative CAD-CAM and intraoperative volume loss assessment.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 01/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Orbital wall fractures 6 months Patients with orbital wall fractures. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age from 5 to 40 years. - Both sexes. - Patients with pure or impure orbital wall fractures. - Patients with unilateral or bilateral orbital wall fractures. - Positive forced-duction test. - Extra-ocular muscle entrapment on face computed tomography (CT) scan. - Posttraumatic clinical enophthalmos or dystopia with orbital fractures. - A medical condition affecting bone healing. - Medically compromised conditions, not a proper candidate for general anesthesia. - Tumor case, encroaching on the orbital walls. - Pathological orbital blowout fractures. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Child: 6 Year-12 Year 5 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/06/2022 Ethical committee
Ethics Committee Address
Street address City Postal code Country
Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia Governorate Menoufia 32951 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Operative time Intraoperatively
Secondary Outcome Quality of reduction 3 months after surgery
Secondary Outcome Incidence of complications 3 months after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt Menoufia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia University Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt Menoufia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia University Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt Menofia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Fouad Mohamed Ghareeb Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt Menofia Egypt
Hossam Hassan Fawzy Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt Menoufia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mashaly ahmedfawzi.mashali@gmail.com 00201032503075 Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt
City Postal code Country Position/Affiliation
Menoufia Egypt Assistant Lecturer
Role Name Email Phone Street address
Scientific Enquiries Fouad Ghareeb drfoadghareeb@gmail.com 00201222126011 Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt
City Postal code Country Position/Affiliation
Menofia Egypt Professor
Role Name Email Phone Street address
Public Enquiries Hossam Fawzy hossam.hassan123@med.menofia.edu.eg 00201067946894 Gamal Abd El-Nasir, Qism Shebeen El-Kom, Shibin el Kom, Menofia, Governorate, Egypt
City Postal code Country Position/Affiliation
Menofia Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data will be available upon a reasonable request from the corresponding author after the end of study for one year. Study Protocol After the end of study for one year. The data will be available upon a reasonable request from the corresponding author.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information