Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001275257
Ethics application status
Approved
Date submitted
19/06/2018
Date registered
27/07/2018
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Epiretinal membrane development after laser therapy for retinal break
Scientific title
Epiretinal membrane formation after laser retinopexy for peripheral breaks. A Spectral domain OCT based study
Secondary ID [1] 295253 0
None
Universal Trial Number (UTN)
U1111-1215-8888
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
retinal tear 308423 0
epiretinal membrane 308424 0
Condition category
Condition code
Eye 307411 307411 0 0
Diseases / disorders of the eye
Eye 307412 307412 0 0
Normal eye development and function

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Patient presenting to the retina service with a fresh retinal tear would be invited to participate. Upon joining the study, an optical coherence tomography test would be done, then after laser therapy, the patient would be asked to follow up in one month. The optical Coherence tomography image of the retina is done specifically looking for an epiretinal membrane. This non invasive image of the fovea would be repeated on a monthly basis for 2 years.
Intervention code [1] 301588 0
Diagnosis / Prognosis
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306386 0
epiretinal membrane development by Optical coherence tomography. There is usually a hyper-reflective membrane at the inner surface of the retina. this is the start of a cellophane.
Timepoint [1] 306386 0
monthly images for 2 years
Secondary outcome [1] 348312 0
risk factors for epiretinal membrane formation: We will be looking at the tear location as described by the retina specialist. OCT would be done on a monthly basis to look at the possibility of an epiretinal membrane developing.
Timepoint [1] 348312 0
monthly assessment for 2 years
Secondary outcome [2] 348624 0
number of tears: This also would be retrieved from the patient's chart.
Timepoint [2] 348624 0
2 years; looking at the same monthly OCT.
Secondary outcome [3] 348848 0
Vitreous Hemorrhage; this will be retrieved from the patient's chart
Timepoint [3] 348848 0
this finding will be assessed on study entry only looking at the patient's chart.
Secondary outcome [4] 348849 0
Treatment Fashion
Timepoint [4] 348849 0
this will be assessed only on study entry looking at the patient's chart and the laser log.

Eligibility
Key inclusion criteria
patients presenting with a fresh retinal tear; able to sign consent form; able to come on a monthly basis for 2 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
inability to image the retina. previous intraocular surgeries. Previous intraocular injections. Previous retinal laser treatment. Other foveal pathologies

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
we are looking at the rate of epiretinal membrane formation after laser treatment for fresh peripheral retinal tears. A sample of 50 patients seemed adequate to catch a good number of epiretinal membrane and calculate risk factors. Bivariate analysis needed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2018
Actual
Date of last participant enrolment
Anticipated
30/09/2018
Actual
Date of last data collection
Anticipated
30/09/2020
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 10575 0
Lebanon
State/province [1] 10575 0

Funding & Sponsors
Funding source category [1] 299845 0
Self funded/Unfunded
Name [1] 299845 0
Country [1] 299845 0
Primary sponsor type
Individual
Name
Haytham Salti
Address
American Unviersity of Beirut Medical Center
Po Box 11 0236-
Riad El Solh
Beirut Lebanon
Country
Lebanon
Secondary sponsor category [1] 299197 0
Individual
Name [1] 299197 0
Ahmad Mansour
Address [1] 299197 0
Beirut Government University Hospital
Pobox 211-Ghbayreh
Beirut Lebanon
Country [1] 299197 0
Lebanon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300722 0
Institutional Review Board- American University of Beirut
Ethics committee address [1] 300722 0
Aubmc
pOBOX 110236
RIAD eL SOLH Beirut
Lebanon
Ethics committee country [1] 300722 0
Lebanon
Date submitted for ethics approval [1] 300722 0
Approval date [1] 300722 0
01/03/2018
Ethics approval number [1] 300722 0

Summary
Brief summary
Epiretinal membrane is known to happen after laser surgery for a retinal tear. We look at the incidence using advanced imaging tools with high resolution. Patients presenting with a retinal tear will be invited to come on a monthly basis and get an image looking for an epiretinal membrane formation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84598 0
A/Prof Haytham Salti
Address 84598 0
Department of Ophthalmology, American University of Beirut Medical Center
Po Box 110236

Beirut Riad EL solh
Lebanon
Country 84598 0
Lebanon
Phone 84598 0
+9613776683
Fax 84598 0
+9611370837
Email 84598 0
[email protected]
Contact person for public queries
Name 84599 0
Haytham Salti
Address 84599 0
Department of Ophthalmology
Faculty of Medicine, AUBMC
P O Box 110236, Beirut LEBANON
Country 84599 0
Lebanon
Phone 84599 0
+9613776683
Fax 84599 0
+9611370837
Email 84599 0
[email protected]
Contact person for scientific queries
Name 84600 0
Haytham Salti
Address 84600 0
Department of Ophthalmology
American University of Beirut Medical Center
P O Box 110236, Beirut LEBANON
Country 84600 0
Lebanon
Phone 84600 0
+9613776683
Fax 84600 0
Email 84600 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.