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Trial registered on ANZCTR


Registration number
ACTRN12622000564752
Ethics application status
Approved
Date submitted
20/11/2020
Date registered
12/04/2022
Date last updated
12/04/2022
Date data sharing statement initially provided
12/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Epiretinal Membrane Surgery with Internal Limiting Membrane Abrasion Technique on Visual Acuity and Central Foveal Thickness
Scientific title
A Comparision of the Effect of Standard Internal Limiting Membrane Peeling with Internal Limiting Membrane Abrasion Technique on Visual Acuity and Central Foveal Thickness in Patients Undergoing Primary Epiretinal Membrane Surgery
Secondary ID [1] 301337 0
None
Universal Trial Number (UTN)
U1111-1252-2975
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epiretinal Membrane 317540 0
Condition category
Condition code
Eye 315631 315631 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
- Historical patient records from Ankara Ulucanlar Eye Training and Research Hospital between 2/01/2014 and 30/09/2018 were reviewed.
- Patients who underwent epiretinal membrane (ERM) surgery with inner limiting membrane (ILM) peeling were included in the study.
- While one of the surgeons (M. Citirik) performed the AIP technique, the other surgeon (MY. Teke) performed the SIP technique, where each surgery takes around one hour.
- In AIP Technique, after the dye aspiration, a diamond-dusted membrane scraper (DMSS, Dorc, Dutch) was brushed over the macula within an area of two-disc diameter surrounding the ERM. Initially, a flap was created using a gentle sweep of a diamond-dusted membrane scraper across the ILM surface. To avoid formation of irregular abrasions and tearing of underlying tissue, DDMS was gently angled with its more rounded surface exposed along the tip’s exterior angle when brushing the ILM.
- The optical coherence tomography (OCT) images were examined by a retina specialist who was masked to the patient and visual acuity outcomes. Retinal architecture and central retinal thickness (CRT) measurements were evaluated with the OCT.
Intervention code [1] 317632 0
Not applicable
Comparator / control treatment
- Historical patient records from Ankara Ulucanlar Eye Training and Research Hospital between 2/01/2014 and 30/09/2018 were reviewed.
- Patients who underwent ERM surgery with standard ILM peeling (SIP) are considered in the control group.
- In the SIP technique, the internal limiting membrane (ILM) was peeled using a pinch technique with Grieshaber DSP 25-G end-gripping forceps (Schaffhausen, Switzerland) and a peel radius of approximately two-disc diameters. In case of incomplete staining of the ILM with adherent pre-ILM tissue, a normally stained area of ILM was selected and the peeling was initiated from there. The ILM was hence peeled en bloc.
- The thechnique was used by MY Teke in surgeries taking approximately one hour.
- The optical coherence tomography (OCT) images were examined by a retina specialist who was masked to the patient and visual acuity outcomes. Retinal architecture and central retinal thickness (CRT) measurements were evaluated with the OCT.
Control group
Active

Outcomes
Primary outcome [1] 323867 0
The first primary outcome measure was the mean change in best-corrected visual acuity (BCVA) for each group. BCVA was measured using the Snellen chart. Snellen values were converted to the logMAR for statistical analysis.
Timepoint [1] 323867 0
6 months post-surgery
Primary outcome [2] 329005 0
The second primary outcome measure was the mean change in central retinal thickness (CRT) for each group. CRT was defined as the highest value on the standard Spectralis spectral-domain optical coherence tomography (SD-OCT) retinal thickness map.
Timepoint [2] 329005 0
6 months post-surgery
Secondary outcome [1] 383089 0
Secondary outcome measures included the mean change for each treatment group in the BCVA change by the SD-OCT. BCVA was measured using the Snellen chart. Snellen values were converted to the logMAR for statistical analysis.
Timepoint [1] 383089 0
At 12 and 24 months post-surgery
Secondary outcome [2] 401141 0
Secondary outcome measures included the mean change for each treatment group in the change in CRT by the SD-OCT. CRT was defined as the highest value on the standard Spectralis spectral-domain optical coherence tomography (SD-OCT) retinal thickness map.
Timepoint [2] 401141 0
At 12 and 24 months post-surgery

Eligibility
Key inclusion criteria
Patients with primary (idiopathic) ERM
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who had any kind of medication, who had >6 diopter myopia, or who had a history of systemic and ocular disease were not included in the study.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/01/2016
Date of last participant enrolment
Anticipated
Actual
30/09/2020
Date of last data collection
Anticipated
Actual
30/09/2020
Sample size
Target
60
Accrual to date
Final
59
Recruitment outside Australia
Country [1] 22563 0
Turkey
State/province [1] 22563 0
Ankara

Funding & Sponsors
Funding source category [1] 305770 0
Hospital
Name [1] 305770 0
Ankara Ulucanlar Eye Training and Research Hospital
Country [1] 305770 0
Turkey
Primary sponsor type
Hospital
Name
Ankara Ulucanlar Eye Training and Research Hospital
Address
University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital, Ulucanlar Cd. No: 59, 06240, Altindag/Ankara
Country
Turkey
Secondary sponsor category [1] 310744 0
Individual
Name [1] 310744 0
Mehmet Citirik
Address [1] 310744 0
University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital, Ulucanlar Cd. No: 59, 06240, Altindag/Ankara
Country [1] 310744 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306044 0
Diskapi Yildirim Beyazit Training and Research Hospital
Ethics committee address [1] 306044 0
Ziraat Mah. Sehit Ömer Halisdemir Cad. No: 20 0611, Diskapi/ANKARA
Ethics committee country [1] 306044 0
Turkey
Date submitted for ethics approval [1] 306044 0
21/05/2020
Approval date [1] 306044 0
10/08/2020
Ethics approval number [1] 306044 0

Summary
Brief summary
This study aims to evaluate the central foveal thickness and visual outcomes of the standard internal limiting membrane (ILM) peeling technique in comparison with the ILM abrasion technique in the primary epiretinal membrane (ERM) surgery.
The hypothesis was that abrasion of the ILM with a diamond-dusted membrane scraper at ERM surgery may be more effective than the standard ILM peeling technique in terms of visual acuity and CRT.
Trial website
Trial related presentations / publications
Public notes
Since this is a retrospective study, ethics approval was obtained after last participant enrolment.

Contacts
Principal investigator
Name 102526 0
Dr Fatma Bagci
Address 102526 0
University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital,
Ulucanlar Cd. No: 59, 06240, Altindag, Ankara
Country 102526 0
Turkey
Phone 102526 0
+903123126261
Fax 102526 0
Email 102526 0
[email protected]
Contact person for public queries
Name 102527 0
Fatma Bagci
Address 102527 0
University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital,
Ulucanlar Cd. No: 59, 06240, Altindag, Ankara
Country 102527 0
Turkey
Phone 102527 0
+903123126261
Fax 102527 0
Email 102527 0
[email protected]
Contact person for scientific queries
Name 102528 0
Fatma Bagci
Address 102528 0
University of Health Sciences, Ankara Ulucanlar Eye Training and Research Hospital,
Ulucanlar Cd. No: 59, 06240, Altindag, Ankara
Country 102528 0
Turkey
Phone 102528 0
+903123126261
Fax 102528 0
Email 102528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9805Ethical approval    379867-(Uploaded-20-11-2020-05-17-37)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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