Sutureless band and chandelier-assisted laser retinopexy for scleral buckling

ISRCTN	ISRCTN38727845
DOI	https://doi.org/10.1186/ISRCTN38727845
Secondary identifying numbers	0302183

Submission date: 07/11/2017
Registration date: 09/11/2017
Last edited: 09/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Amir Gomaa
Scientific

2 Sayadla Street, Smouha
Alexandria
21615
Egypt

ORCID ID	0000-0002-3263-6957

Study information

Study design	Single-center unmasked uncontrolled interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Applying sutureless encircling # 41 band and trans-scleral chandelier-assisted laser retinopexy for scleral buckling procedure
Study objectives	A combination of sutureless band, laser, and chandelier illumination can successfully treat retinal detachment.
Ethics approval(s)	Ethics committee Faculty of Medicine, Alexandria University, 26/02/2014, IRB NO: 00007555-FWA NO: 00015712
Health condition(s) or problem(s) studied	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
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 study start date	01/11/2013
Completion date	01/11/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	30
Key inclusion criteria	Recent onset rhegmatogenous retinal detachment
Key exclusion criteria	1. Media opacity 2. Proliferative vitreoretinopathy 3. Giant retinal tear 4. Macular hole 5. Children 6. High myopes
Date of first enrolment	26/02/2014
Date of final enrolment	26/02/2015

Locations

Countries of recruitment

Egypt

Study participating centre

Alexandria University

Faculty of Medicine
Khartoum Square
Azarita
Alexandria
21514
Egypt

Sponsor information

Alexandria University
University/education

Faculty of Medicine
Khartoum Square
Alexandria
21514
Egypt

Phone	+20 (3) 4810728
Email	med-dean@alexu.edu.eg
Website	www.med.alexu.edu.eg/
"ROR"	https://ror.org/00mzz1w90

Funders

Funder type

University/education

Alexandria Faculty of Medicine, Alexandria University
Private sector organisation / Universities (academic only)

Alternative name(s): Alexandria University Faculty of Medicine
Location: Egypt

Results and Publications

Intention to publish date	01/12/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in the Journal of Ophthalmology.
IPD sharing plan	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.