Plain English Summary
Background and study aims
Retinal detachment occurs when the thin lining at the back of the eye (retina) pulls away from the blood vessels that supply it with oxygen and nutrients. An operation is needed to reattach the retina, such as scleral buckling, which involves fine bands being stitched on to the outside white of the eye (the sclera). Laser or freezing treatment is used to close up the tear or hole between the retina and the wall of the eye. Despite the high success rate of scleral buckling for uncomplicated retinal detachment, the surgery is associated with complications related to the technique. Improving the technique of scleral buckling would maintain the high success rate while decreasing the complications. This could include the surgeon using a different lighting and viewing system, using bands instead of broad buckles, using a laser instead of freezing treatment, and not using scleral sutures (stitches). The aim of this study is to assess whether these changes in the standard scleral buckling technique maintain the high success rate while limiting complications.
Who can participate?
Patients with recent retinal detachment
What does the study involve?
All participants undergo the modified scleral buckling technique. Retinal attachment, vision and complications are assessed at 1, 3 and 6 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Alexandria University (Egypt)
When is the study starting and how long is it expected to run for?
November 2013 to November 2015
Who is funding the study?
Alexandria Faculty of Medicine, Alexandria University (Egypt)
Who is the main contact?
Dr Amir Gomaa
Trial website
Contact information
Type
Scientific
Primary contact
Dr Amir Gomaa
ORCID ID
http://orcid.org/0000-0002-3263-6957
Contact details
2 Sayadla Street
Smouha
Alexandria
21615
Egypt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0302183
Study information
Scientific title
Applying sutureless encircling # 41 band and trans-scleral chandelier-assisted laser retinopexy for scleral buckling procedure
Acronym
Study hypothesis
A combination of sutureless band, laser, and chandelier illumination can successfully treat retinal detachment.
Ethics approval
Ethics committee Faculty of Medicine, Alexandria University, 26/02/2014, IRB NO: 00007555-FWA NO: 00015712
Study design
Single-center unmasked uncontrolled interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Rhegmatogenous retinal detachments
Intervention
A modified technique for scleral buckling which includes using sutureless encircling # 41 band and trans-scleral chandelier-assisted laser retinopexy. The technique involved 360 degree periotomy, hanging the 4 recti, sutureless fixation of band number 41, then inserting the chandelier light and using the wide angle viewing system and the diode laser for retinopexy followed by drainage of subretinal fluid if needed. The total duration of follow up is 6 month.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Retinal attachment, evaluated by fundus examination at 1, 3 and 6 months
Secondary outcome measures
1. Complications, evaluated by fundus examination at 1, 3 and 6 months
2. Visual acuity, measured by Snellen chart and converted to log Mar at baseline, 1, 3 and 6 months
Overall trial start date
01/11/2013
Overall trial end date
01/11/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Recent onset rhegmatogenous retinal detachment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Media opacity
2. Proliferative vitreoretinopathy
3. Giant retinal tear
4. Macular hole
5. Children
6. High myopes
Recruitment start date
26/02/2014
Recruitment end date
26/02/2015
Locations
Countries of recruitment
Egypt
Trial participating centre
Alexandria University
Faculty of Medicine
Khartoum Square
Azarita
Alexandria
21514
Egypt
Sponsor information
Organisation
Alexandria University
Sponsor details
Faculty of Medicine
Khartoum Square
Alexandria
21514
Egypt
+20 (3) 4810728
med-dean@alexu.edu.eg
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Alexandria Faculty of Medicine, Alexandria University
Alternative name(s)
Alexandria University Faculty of Medicine
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Egypt
Results and Publications
Publication and dissemination plan
Planned publication in the Journal of Ophthalmology.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Amir Gomaa. All participants' consent was obtained and anonymisation was maintained.
Intention to publish date
01/12/2018
Participant level data
Available on request
Basic results (scientific)
Publication list