Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000663954
Ethics application status
Approved
Date submitted
15/12/2008
Date registered
29/06/2011
Date last updated
29/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The presence of cystoid macular oedema after cataract extraction as measured by optical coherence tomography.
Scientific title
The presence of cystoid macular oedema after cataract extraction as measured by optical coherence tomography.
Secondary ID [1] 262532 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystoid macular oedema 4135 0
Condition category
Condition code
Eye 4333 4333 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
100 eyes of 80 consecutive cataract patients were included in this study. All participants were diagnosed with cataract which required extraction which was performed by one of two surgeons. Routine surgical protocols for cataract extraction were observed. Participants were examined prior to surgery and both best corrected visual acuity and 'Optical Coherence Tomography' (OCT) was performed pre-operatively, 1 week post-operatively and 4 weeks post operatively. OCT is a non-invasive, in vivo cross-sectional imaging of the retina.
Intervention code [1] 3846 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5218 0
OCT was performed within 1 month pre-operatively in addition to 1 week, 4 weeks and 6 months post-operatively. OCT was acquired using the fast macular thickness scan protocol of the Time-Domain Stratus OCT (Carl Zeiss Pty Ltd) to obtain six consecutive macular scans centred on the fovea. The Retinal Thickness Tabular Output Report was used to generate mean CFT in the circle at 1mm diameter (central fovea), 3mm (inner macular) and 6mm (outer macula)
Timepoint [1] 5218 0
1 month pre-operatively in addition to 1 week, 4 weeks and 6 months post-operatively
Secondary outcome [1] 8785 0
Best corrected visual acuity (non-illuminated logMAR)
Timepoint [1] 8785 0
1 month pre-operatively in addition to 1 week, 4 weeks and 6 months post-operatively

Eligibility
Key inclusion criteria
Participants with cataract suitable for surgical extraction.
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unsuccessful pre-operative OCT scanning.
Surgical complications.

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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1347 0
3000

Funding & Sponsors
Funding source category [1] 4301 0
Self funded/Unfunded
Name [1] 4301 0
Dr Meri Vukicevic
Country [1] 4301 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Eye Surgery Associates
Address
Level 5, 200 High Street
Doncaster Victoria 3108
Country
Australia
Secondary sponsor category [1] 3873 0
None
Name [1] 3873 0
Address [1] 3873 0
Country [1] 3873 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6348 0
La Trobe University Faculty Human Ethics Committee
Ethics committee address [1] 6348 0
Faculty of Health Sciences
La Trobe University Victoria 3086
Ethics committee country [1] 6348 0
Australia
Date submitted for ethics approval [1] 6348 0
01/02/2009
Approval date [1] 6348 0
24/03/2009
Ethics approval number [1] 6348 0
FHEC09/01

Summary
Brief summary
Background: Post-operative cystoid macular oedema (CMO) is a complication of uneventful cataract surgery. While improved surgical techniques have decreased the incidence of CMO, it remains a cause of unfavourable visual outcome following surgery. Fundus fluorescein angiography has been the ‘gold standard’ for diagnosing sub-clinical CMO, however non-invasive cross-sectional imaging of the retina with optical coherence tomography (OCT) may be equally effective at detecting the condition and offers the ability to quantify and repeat results over time.
Design: Prospective pre-post case series of patients undergoing routine phacoemulsification surgery.
Participants: Eighty consecutive patients (100 eyes) with cataracts and an age range of 40 to 90 years (M 76.18).
Methods: Macular thickness of participants was determined using time-domain OCT pre-operatively and after surgery at 1 day, 1 week, 4 weeks and 6 months. OCT was used to diagnose post-operative CMO.
Main outcome measures: Presence of cysts at the macula, identified by OCT, in addition to foveal and macular thickness (µm).
Results: CMO was present in 5% of eyes. Macular thickness increased after surgery and central foveal thickness (CFT) increased by almost 7% but returned to pre-operative levels after 6 months. Findings also indicate that patients who developed post-operative CMO had significantly thicker CFT of approximately 5% compared with those that did not.
Conclusions: OCT is a useful, non-invasive diagnostic tool in determining sub-clinical
CMO in uncomplicated cataract surgery patients and detects the presence of retinal thickening and intra-retinal cysts very soon after surgery, thereby facilitating earlier diagnosis and treatment of post-operative CMO.
Trial website
Trial related presentations / publications
Publications:
Vukicevic M, Gin T & Al-Qureshi S. Prevalence of optical coherence tomography-diagnosed post-operative cystoid macular oedema in patients following uncomplicated phacoemulsification cataract surgery. Clinical and Experimental Ophthalmology. (in print)
Public notes

Contacts
Principal investigator
Name 35043 0
Address 35043 0
Country 35043 0
Phone 35043 0
Fax 35043 0
Email 35043 0
Contact person for public queries
Name 12390 0
Dr Meri Vukicevic
Address 12390 0
Department of Clinical Vision Sciences
Division of Allied Health
La Trobe University Victoria 3086
Country 12390 0
Australia
Phone 12390 0
+61 3 9479 1807
Fax 12390 0
Email 12390 0
m.vukicevic@latrobe.edu.au
Contact person for scientific queries
Name 3318 0
Dr Meri Vukicevic
Address 3318 0
Department of Clinical Vision Sciences
Division of Allied Health
La Trobe University Victoria 3086
Country 3318 0
Australia
Phone 3318 0
+61 3 9479 1807
Fax 3318 0
Email 3318 0
m.vukicevic@latrobe.edu.au

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