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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308563611203 Date of Approval: 04/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Correlation between optic nerve sheath diameter in cases of papilledema and the degree of intracranial tension by spinal tab in idiopathic intracranial hypertension
Official scientific title Correlation between optic nerve sheath diameter in cases of papilledema and the degree of intracranial tension by spinal tab in idiopathic intracranial hypertension
Brief summary describing the background and objectives of the trial this study will be carried out to find the correlation between the ONSD measured by ultrasonography and ICP measured by lumber puncture and to assess the feasibility of ultrasonography as a non-invasive technique for follow up of IIH. Patients with idiopathic increased intracranial hypertension will be examined by US to measure ONSD and the results will be correlated by the opening CSF pressure measured by the lumber puncture aiming to find the correlation between both results and using ONSD in diagnosis of ICP .
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 25/07/2023
Actual trial start date 30/07/2022
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date 30/09/2023
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ERN:MED2/72022s.no48OPT92402
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lumbar puncture once and repeated if needed in follow up opening CSF pressure will be measured by lumbar puncture by an anaesthetic under supervision of neurosurgeon according to a standard procedure, LP will be done in supine left lateral position after good sterilization. The needle will be inserted between L4/5 space or one level higher (L3/4). the opening pressure will be calculated while the patient in recombinant position. Recording the ICP will be done in cmH2O. Initial and final ICP values will be recorded. In case of pressure is over 30 cmh20 , the anaesthetist will withdraw of 20 to 40 cc of CSF according to the patient tolerance aiming to decrease ICP . 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age from 14 years up to 65 year old. • Bilateral papilledema confirmed by ophthalmoscopy, fundus photo and fluorescein angiography. • Presence of signs of ICP including headache, nausea and vomiting • Patients with history of glaucoma • Patients with history of orbital or previous ocular surgery • Patients with MRI or CT reveals space occupying lesions, chiari malformation or any other contraindication of LP. • History of bleeding tendency or coagulopathy. • Patients with optic neuropathy, primary optic atrophy, papillitis. • Patient refuse the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 14 Year(s) 65 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 02/07/2022 Port said university
Ethics Committee Address
Street address City Postal code Country
23 December st port said 066 Egypt
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 02/07/2022 Port said university
Ethics Committee Address
Street address City Postal code Country
23.december street port said 066 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome optic nerve sheath diameter just before lumber puncture
Secondary Outcome intracranial tension after measurement of ONSD
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Port said university El-Sayda Khadega ,st . Portsaid Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
health insurance 23, july ,st . port said Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Egyption health insurance system port said port said Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Portsaid university El-Sayda Khadega, st . Port said Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ehab Ghonem ehabghoneim@hotmail.com 01096112481 port said
City Postal code Country Position/Affiliation
port said Egypt port said university
Role Name Email Phone Street address
Principal Investigator Ayman Galhom Aiman2gm@hotmail.com +0201007179379 port said
City Postal code Country Position/Affiliation
port said Egypt port said university
Role Name Email Phone Street address
Public Enquiries raghda Elgendy raghd_ophth@yahoo.com +0201007218377 Saad zaghlol street
City Postal code Country Position/Affiliation
mansura Egypt Port said university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes optic nerve sheath diameter is measured and compared with the lumber puncture results done by the neurosergeon individual participant data that underlie the results reported in this article after de identification( text , tables , figures and appendices ) Study Protocol 2023-2024 for one year publishing the results in international journals
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