Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000997459p
Ethics application status
Submitted, not yet approved
Date submitted
25/07/2016
Date registered
28/07/2016
Date last updated
28/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of macula function recovery using MAIA microperimetry after Epiretinal membrane peeling surgery.
Scientific title
Assessment of macula function recovery using MAIA microperimetry after Epiretinal membrane peeling surgery.
Secondary ID [1] 289749 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epiretinal Membrane 299598 0
Vitreoretinal Surgery 299657 0
Condition category
Condition code
Eye 299568 299568 0 0
Diseases / disorders of the eye
Surgery 299602 299602 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients who are diagnosed with Epiretinal Membrane who will undergo microperimetric testing pre and Pars plana vitrectomy membrane peeling surgery.

Exposure being studied in this study: Fundus- driven microperimetry

Microperimetry is a technology that allows concurrent analysis of structural and functional aspects of the retina. It combines fundus imaging, retinal sensitivity mapping and fixation analysis in one exam and has been used over a decade as a powerful tool to detect,
describe and follow-up pathologies affecting the macular area. Its great advantage is the ability to track patients’ fixation activity while measuring visual field, hence eliminating errors caused by fixation losses. It is a non-invasive test and can be easily performed by most patients including those with low vision. It works by presenting light stimuli it a unit (one eye is occluded at a time) and the patient is given a button which they press when the stimulus is detected.

The microperimetry test will be conducted on the patients by a member of the research team (Ophthalmic registrar, clinical research officer) using a standardised protocol at the clinic. The test takes approximately 5 mins per eye. We will try to ensure the same operator will conduct subsequent follow up test for a particular patient. The baseline test will be performed within 4 weeks prior to the patient undergoing surgery and then at 1,3,6 and 12 months post surgery. The data will be collected at these time points.
Intervention code [1] 295393 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299040 0
Macular function- this is measured as a change in microperimetric parameters including:
1. Average threshold (dB)
2. Central threshold (dB)
3. Macular Integrity
4. Fixation stability
Timepoint [1] 299040 0
Change in all parameters mentioned above from baseline will be recorded at 1, 3, 6 and 12 months post operatively.
Secondary outcome [1] 325950 0
Best corrected visual acuity: this will be measured using standard Snellen's chart at 6m
Timepoint [1] 325950 0
Change in best corrected visual acuity from baseline will be recorded at 1, 3, 6 and 12 months post operatively.
Secondary outcome [2] 326074 0
Central macular thickness: This will be measured using SD-OCT (Heidelberg) and measured in micrometers using a drawn vector.

Central macular thickness (CMT) is defined as the distance between the vitreoretinal interface and the anterior surface of the RPE. A vector will be drawn between these two points and distance measured which will provide the CMT. This will be done by same operator per patient.
Timepoint [2] 326074 0
Change in central macular thickness from baseline will be recorded at 1, 3, 6 and 12 months post operatively.

Eligibility
Key inclusion criteria
1. Ability to provide informed consent and complete study assessments
2. Age 18 years or older
3. Best corrected baseline visual acuity between 6/60 to 6/9 in the study eye with a documented drop in BCVA
4. Diagnosed with Epiretinal membrane and consented to undergo ERM peeling surgery
5. Persistent metamorphopsia or micropsia for a period of at least 6 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy or lactation
2. Intraocular surgery in the study eye within 2 months of baseline
3. Macular laser within 2 months or previous laser scar would prevent the improvement of macular function
4. Prior vitrectomy in the study eye
5. Current vitreous haemorrhage in the study eye
6. Active proliferative diabetic retinopathy in study eye
7. Active uveitis in study eye
8. Uncontrolled glaucoma in the study eye defined as intraocular pressure greater than 30mmHg on maximal medical therapy
9. Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
10. An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)
11. Uncontrolled diabetes mellitus, as defined by hemoglobin A1C (HbA1c) > 12%
12. Dense lens media opacity
13. History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
14. Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Study outcomes will be compared between baseline and follow up visits using paired T test as well as Pearsons correlation analysis to assess association between variables.

There is no formal power calculation performed for this study. Study population recruitment target size chosen for this study has been based on cohort numbers seen in previous similar studies in the literature and this is cohort size will also be make it feasible to complete this project in the prescribed time frame.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
24/04/2017
Actual
Date of last data collection
Anticipated
30/10/2017
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment hospital [1] 6243 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment hospital [2] 6244 0
Canberra Eye Hospital - Symonston
Recruitment postcode(s) [1] 13668 0
2000 - Sydney
Recruitment postcode(s) [2] 13669 0
2609 - Symonston

Funding & Sponsors
Funding source category [1] 294132 0
Hospital
Name [1] 294132 0
Sydney Retina Clinic and Day Surgery
Country [1] 294132 0
Australia
Primary sponsor type
Hospital
Name
Sydney Retina Clinic and Day Surgery
Address
187 Macquarie St
Sydney NSW 2000
Parkhouse Building Level 13
Country
Australia
Secondary sponsor category [1] 292963 0
None
Name [1] 292963 0
Address [1] 292963 0
Country [1] 292963 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295546 0
Research Integrity & Ethics Administration University of Sydney
Ethics committee address [1] 295546 0
The University of Sydney
Research Integrity and Ethics Administration Department
Level 2 , Margaret Telfer Building (K07), The University of Sydney, NSW
2006
Ethics committee country [1] 295546 0
Australia
Date submitted for ethics approval [1] 295546 0
11/04/2016
Approval date [1] 295546 0
Ethics approval number [1] 295546 0

Summary
Brief summary
Study Design: This is a prospective, non-randomised observational study which will follow post operative progress of patients who have been diagnosed with symptomatic Epiretinal membrane and will undergo epiretinal membrane peeling surgery over a 12 month period.

Population: 100 eligible subjects will be recruited from Sydney Retina Clinic & Day Surgery, Australia.

Study Duration: The study will be conducted over 18 months (6-month recruitment period and 12 month treatment and follow up period).

Primary Objective: To evaluate the rate and amount of macular functional recovery using visual acuity, MAIA microperimetry and visual functioning questionnaires and to correlate this with anatomical change on SD OCT over 12 months. The aim will also be to determine prognostic indicators of poor visual outcome post surgery. 3. The change of retinal function measured by Macular Integrity Assessment (MAIA) microperimetry (including central threshold, average threshold, fixation stability and macular integrity) at months 1, 3, 6 and 12 months.

Secondary Objectives:
1. Mean change in visual acuity at months 1, 3, 6 and 12 compared to the baseline using snellens chart at 6m
2. Mean change in central macular thickness measured by SD-OCT at months 1, 3, 6 and 12 compared to the baseline
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67666 0
A/Prof Andrew Chang
Address 67666 0
Sydney Retina Clinic and Day Surgery
Level 13/187 Macquarie St
Sydney NSW 2000
Country 67666 0
Australia
Phone 67666 0
+612 9221 3755
Fax 67666 0
+612 9221 1637
Email 67666 0
[email protected]
Contact person for public queries
Name 67667 0
Dr Thomas Hong
Address 67667 0
Sydney Retina Clinic and Day Surgery
Level 13/187 Macquarie St
Sydney NSW 2000
Country 67667 0
Australia
Phone 67667 0
+612 9221 3755
Fax 67667 0
+612 9221 1637
Email 67667 0
[email protected]
Contact person for scientific queries
Name 67668 0
Dr Rashmi Nair
Address 67668 0
Sydney Retina Clinic and Day Surgery
Level 13/187 Macquarie St
Sydney NSW 2000
Country 67668 0
Australia
Phone 67668 0
+612 9221 3755
Fax 67668 0
+612 9221 1637
Email 67668 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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