Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001456246
Ethics application status
Approved
Date submitted
8/08/2018
Date registered
29/08/2018
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Retinal changes detected after uneventful unilateral cataract surgery in otherwise healthy subjects
Scientific title
Spectral domain OCT changes detected after uneventful unilateral phacoemulsification surgery in otherwise healthy subjects
Secondary ID [1] 295375 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cataract surgery 308610 0
Condition category
Condition code
Eye 307561 307561 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
Patients will be recruited at the American university of Beirut medical centre (AUBMC) by Dr. Haytham Salti, ophthalmologist specialist in retina.
60 healthy individuals who will undergo medically indicated phacoemulsification surgery in one eye will be recruited (surgery indicated and will be done regardless of their participation in the study)
Spectral domain optical coherence tomography (OCT) will be done preoperatively, 1 month and 3 months postoperatively to check for any macular changes (macular thickness, cystic formation and macular edema) compared to the fellow (phakic) eye.
Intervention code [1] 301698 0
Diagnosis / Prognosis
Comparator / control treatment
non operated eye (no cataract surgery in the other eye)
Control group
Active

Outcomes
Primary outcome [1] 306535 0
macular thickness measured by optic coherence tomography after cataract surgery
Timepoint [1] 306535 0
preoperatively and postoperatively at 1 month (primary endpoint) and 3 months
Secondary outcome [1] 348801 0
macular cystic formation detected by OCT after cataract surgery
Timepoint [1] 348801 0
preoperatively and postoperatively, at 1 month and 3 months
Secondary outcome [2] 351114 0
macular edema detected by OCT after cataract surgery
Timepoint [2] 351114 0
preoperatively and postoperatively, at 1 month and 3 months

Eligibility
Key inclusion criteria
- media opacity due to cataract was moderate and OCT examination can be performed on both eyes
- grade 1 or 2 nuclear/cortical cataract or visually significant cataract
- no macular pathology
- no glaucoma or other ocular pathology
- phakic fellow eye (no cataract surgery in the other eye)
- no diabetes mellitus or any other systemic disease that could affect vision
- no amblyopia
- good cooperation in the treatment and follow up protocol
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- media opacification for reasons other than cataract
- pre existing retinal pathologies such as epiretinal membrane, macular hole or age related macular degeneration and other retinopathies such as vascular occlusion and retinal dystrophy
- pre existing ocular disease such as glaucoma, uveitis or amblyopia
- diabetes mellitus or other systemic disease that could affect the eye
- those undergoing systemic treatment with drugs that could affect the eye

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 10599 0
Lebanon
State/province [1] 10599 0
Beirut

Funding & Sponsors
Funding source category [1] 299967 0
Hospital
Name [1] 299967 0
American university of Beirut Medical Centre
Country [1] 299967 0
Lebanon
Primary sponsor type
Individual
Name
Haitham Salti
Address
American University Of Beirut Medical Center, Cairo Street, Hamra, Beirut, Lebanon
Country
Lebanon
Secondary sponsor category [1] 299347 0
None
Name [1] 299347 0
none
Address [1] 299347 0
none
Country [1] 299347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300829 0
Institutional review board American University Of beirut
Ethics committee address [1] 300829 0
American University of Beirut
PO BOX: 11-0236 F15
Riad El Solh, Beirut 1107 2020
Lebanon
Ethics committee country [1] 300829 0
Lebanon
Date submitted for ethics approval [1] 300829 0
Approval date [1] 300829 0
18/05/2018
Ethics approval number [1] 300829 0

Summary
Brief summary
The study is designed to check if there is any retinal changes (at the level of the macula) that occurs post cataract surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84950 0
A/Prof Haitham Salti
Address 84950 0
Riad el Solh, Beirut, Lebanon
Building: Medical Center - Phase (1 )/Floor: 7/Room: C-746
work organisation American university of Beirut
RIad el Solh, Beirut Lebanon
Country 84950 0
Lebanon
Phone 84950 0
+961-1-350000 ext: 5550
Fax 84950 0
Email 84950 0
[email protected]
Contact person for public queries
Name 84951 0
Dr Nasrine Anais El Salloukh
Address 84951 0
Riad el Solh, Beirut, Lebanon
Building: Medical Center - Phase (1 )/Floor: 7
work organisation American university of Beirut
RIad el Solh, Beirut Lebanon
Country 84951 0
Lebanon
Phone 84951 0
+961-1-350000 ext: 5550
Fax 84951 0
Email 84951 0
[email protected]
Contact person for scientific queries
Name 84952 0
Dr Nasrine Anais El Salloukh
Address 84952 0
Riad el Solh, Beirut, Lebanon
Building: Medical Center - Phase (1 )/Floor: 7
work organisation American university of Beirut
RIad el Solh, Beirut Lebanon
Country 84952 0
Lebanon
Phone 84952 0
+961-1-350000 ext: 5550
Fax 84952 0
Email 84952 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

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