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.: PACTR202210479766926 Date of Approval: 17/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Retinal displacement after vitrectomy
Official scientific title Retinal Displacement Following Successful Pars Plana Vitrectomy for Rhegmatogenous Retinal Detachment
Brief summary describing the background and objectives of the trial Background: The appearance of hyper-fluorescent lines next to the retinal blood vessels after successful retinal detachment surgery was explained by the occurrence of retinal displacement. This can attribute to the metamorphopsia experienced by some patients after their surgeries. objectives: This work aimed at studying the incidence of retinal displacement and its related risk factors after retinal detachment surgery for rhegmatogenous detachment.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 01/06/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitrectomy surgery surgery within 2 weeks of the detachment retinal detachment surgery via pars plana vitrectomy (PPV) with silicone oil tamponade 30
Control Group vitrectomy with gas tamponade within 2 weeks of detachment vitrectomy surgery with gas tamponade 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
fresh rhegmatogenous retinal detachment 1) Patients with recurrent rhegmatogenous retinal detachment. 2) Patients with combined rhegmatogenous and tractional retinal detachment 3) Patients with high myopia (axial length more than 26mm). 4) Media opacity obscuring adequate clinical evaluation or investigations. 5) Any physical and or mental handicap preventing OCT imaging. 6) Any retinal disease such as DR, BRAO, BRVO. 7) Any optic nerve disease such as Glaucoma or optic neuropathy. 8) Previous intravitreal injection, laser, or vitrectomy. Adult: 19 Year-44 Year 18 Year(s) 80 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 04/11/2020 ethical committee of faculty of medicine Tanta university
Ethics Committee Address
Street address City Postal code Country
El Bahr St. Tanta 31111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome retinal displacement after surgery detected by OCT and FAF images 3 months postop.
Secondary Outcome Metamorphopsia detected by Amsler grid 3 months postop.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El Bahr St Tanta 31111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded elbahr st Tanta 31111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine tanta university El Bahr St. tanta 31111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tamer Wasfy tamer.wasfy@med.tanta.edu.eg +20403332033 Elbahr st
City Postal code Country Position/Affiliation
Tanta 31111 Egypt Assistant professor of ophthalmology
Role Name Email Phone Street address
Public Enquiries Amr Lotfy amrlotfy994@gmail.com +20403332033 Ebahr st
City Postal code Country Position/Affiliation
Tanta 31111 Egypt resident of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Amr Lotfy amrlotfy994@gmail.com +20403332033 Elbahr st
City Postal code Country Position/Affiliation
Tanta 31111 Egypt resident of ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in retinal displacement. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Statistical Analysis Plan Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: tamer.wasfy@med.tanta.edu.eg
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