ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

N/A

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cystoid macular oedema

Condition category

Condition code

Eye

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]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

1 month pre-operatively in addition to 1 week, 4 weeks and 6 months post-operatively

Secondary outcome [1]

Best corrected visual acuity (non-illuminated logMAR)

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3000

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Meri Vukicevic

Address [1]

Department of Clinical Vision Sciences
Division of Allied Health
La Trobe University Victoria 3086

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Faculty Human Ethics Committee

Ethics committee address [1]

Faculty of Health Sciences
La Trobe University Victoria 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/02/2009

Approval date [1]

24/03/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Meri Vukicevic

Address

Department of Clinical Vision Sciences
Division of Allied Health
La Trobe University Victoria 3086

Country

Australia

Phone

+61 3 9479 1807

Fax

m.vukicevic@latrobe.edu.au

Contact person for scientific queries

Name

Dr Meri Vukicevic

Address

Department of Clinical Vision Sciences
Division of Allied Health
La Trobe University Victoria 3086

Country

Australia

Phone

+61 3 9479 1807

Fax

m.vukicevic@latrobe.edu.au

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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No additional documents have been identified.

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