Condition category
Eye Diseases
Date applied
07/11/2017
Date assigned
09/11/2017
Last edited
09/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.med.alexu.edu.eg/

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

academic

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes