Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000699460
Ethics application status
Approved
Date submitted
19/04/2016
Date registered
26/05/2016
Date last updated
26/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Screening for foveal pathology in an adult population using non-mydriatic spectral domain optical coherence tomography
Scientific title
Screening for foveal pathology in an adult population using non-mydriatic spectral domain optical coherence tomography
Secondary ID [1] 289046 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foveal pathology 298471 0
Condition category
Condition code
Eye 298566 298566 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assessment entails a non-mydriatic optical coherence tomography in addition to a comprehensive ophthalmologic evaluation done at the military hospital for adult subjects who happen to be accompanying patients. This single assessment session lasts about 90 minutes It is not repeated. The non mydriatic OCT image is sent to a reading center electronically to be evaluated by a reader.
Intervention code [1] 294532 0
Early Detection / Screening
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298053 0
Rate of detection of irregularities in the foveal area assessed by non-mydriatic Optical Coherence Tomography.
Timepoint [1] 298053 0
90 minutes. Each participant will have one assessment session, starting with a non-mydriatic optical coherence tomography only to be followed by a comprehensive eye evaluation.
Secondary outcome [1] 323061 0
best corrected visual acuity using the ETDRS chart.
Timepoint [1] 323061 0
15 minute; this outcome is assessed at study entry as part of the comprehensive eye examination that each study subject receives.
Secondary outcome [2] 323062 0
Thickness of the fovea using the non-mydriatic optical coherence tomography
Timepoint [2] 323062 0
15 minutes; this is measured during the image interpretation of the acquired NMOCT by the retina specialist in the reading center.

Eligibility
Key inclusion criteria
healthy adult willing to undergo a comprehensive eye examination
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
patients who are not willing to undergo a comprehensive dilated eye examination

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Ideally we would like to screen around 500 eyes, since these abnormalities have been detected in 9% or so in general population using a comprehensive eye examination. Around 250 participant would be needed to look for asymptomatic irregularities in the fovea. Sensitivity, specificity, positive predictive value, negative predictive value, kappa coefficient

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/02/2015
Date of last participant enrolment
Anticipated
10/02/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 7831 0
Lebanon
State/province [1] 7831 0

Funding & Sponsors
Funding source category [1] 293425 0
Self funded/Unfunded
Name [1] 293425 0
Haytham Salti
Country [1] 293425 0
Lebanon
Primary sponsor type
Individual
Name
Haytham Salti
Address
American University of Beirut Medical Center
Maamari Street
Beirut
LEBANON
110236
Country
Lebanon
Secondary sponsor category [1] 292244 0
Hospital
Name [1] 292244 0
American University of Beirut Medical Center
Address [1] 292244 0
Maamari Street
Beirut, LEBANON
110236
Country [1] 292244 0
Lebanon

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294868 0
IRB-Military Hospital Badaro
Ethics committee address [1] 294868 0
IRB Military Hospital
Badaro street, Beirut
Ethics committee country [1] 294868 0
Lebanon
Date submitted for ethics approval [1] 294868 0
11/12/2013
Approval date [1] 294868 0
11/01/2014
Ethics approval number [1] 294868 0

Summary
Brief summary
Purpose: To evaluate non-mydriatic spectral domain optical coherence tomography (NMOCT) as a telemedicine screening tool for adult foveal abnormalities.

Materials and Methods: two hundred and fifty middle-aged subjects will be asked to undergo a NMOCT test. These subjects will also be invited to undergo a comprehensive ophthalmologic evaluation to check for the efficacy of the NMOCT as a telemedicine screening tool in detecting foveal abnormalities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65286 0
A/Prof Haytham Salti
Address 65286 0
American University of Beirut Medical Center
Maamari Street
110236
Country 65286 0
Lebanon
Phone 65286 0
+9613776683
Fax 65286 0
+9611370837
Email 65286 0
hs06@aub.edu.lb
Contact person for public queries
Name 65287 0
Maamoun Abdul Fattah
Address 65287 0
American University of Beirut Medical Center
Maamari Street
Beirut LEBANON
110236
Country 65287 0
Lebanon
Phone 65287 0
+96178845330
Fax 65287 0
Email 65287 0
ma318@aub.edu.lb
Contact person for scientific queries
Name 65288 0
Haytham Salti
Address 65288 0
American University of Beirut Medical Center
Maamari Street
Beirut LEBANON
110236
Country 65288 0
Lebanon
Phone 65288 0
+9613776683
Fax 65288 0
Email 65288 0
hs06@aub.edu.lb

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.