Optical Coherence Tomography Angiography (OCTA) Changes in Patients With Epiretinal Membranes (ERM) With and Without Peeling of the Internal Limiting Membrane (ILM)
Primary Purpose
Epiretinal Membrane of Both Eyes
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
ILM nonpeeling
ILM peeling
Sponsored by
About this trial
This is an interventional treatment trial for Epiretinal Membrane of Both Eyes
Eligibility Criteria
Inclusion Criteria:
- Patient must be able and willing to give informed consent.
- Patient must be over 18 and below 100 years of age.
- Patient must not have any significant media opacity which interferes with the examination.
- Patient must have an epiretinal membrane requiring surgery.
Exclusion Criteria:
- Unwilling or unable to provide informed consent
- Under 18 or over 100 years of age
- Significant media opacities
- Systemic pathologies making an examination difficult or cumbersome to the patient
- Secondary epiretinal membranes
- Bilateral epiretinal membranes
- Macular holes
- Lamellar holes
- Pseudo holes
- Glaucoma
- Diabetes
- Anisometropia > 2 diopters
- High myopia (spherical equivalent > 6 diopters and/or axial length > 26 mm
- Other retinal or ophthalmic pathologies except moderate cataract
- OCTA scan signal strength < 50
- Low image quality
- Failure of automatic layer segmentation
Sites / Locations
- Medical University Graz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ILM nonpeeling
ILM peeling
Arm Description
Outcomes
Primary Outcome Measures
Superficial capillary plexus foveal avascular zone area
Superficial capillary plexus foveal avascular zone area (SCP FAZ) change (preoperative to postoperative). The SCP FAZ represents the area of the macula where blood vessels are not seen in OCTA under physiologic conditions. It has previously been reported that the FAZ narrows during ERM development and enlarges after ERM removal.
Secondary Outcome Measures
Full Information
NCT ID
NCT05287009
First Posted
March 10, 2022
Last Updated
March 18, 2022
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT05287009
Brief Title
Optical Coherence Tomography Angiography (OCTA) Changes in Patients With Epiretinal Membranes (ERM) With and Without Peeling of the Internal Limiting Membrane (ILM)
Official Title
Optical Coherence Tomography Angiography (AngioVueTM, Optovue Inc., Fremont, Calif., USA) Changes in Patients With Epiretinal Membranes (ERM) With and Without Peeling of the Internal Limiting Membrane (ILM) - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
March 9, 2022 (Actual)
Study Completion Date
March 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Main objective
The objective is to compare two surgical options in vitrectomies for epiretinal membranes using parameters of optical coherence tomography angiography.
Background
State of the art treatment for epiretinal membranes consists of pars plana vitrectomy, staining of the epiretinal membrane with a blue colouring dye and epiretinal membrane peeling. The vitrectomized space is filled with fluid (balanced salt solution) during the procedure and the fluid can optionally be replaced with air as a final step. After ERM peeling (but before the selection of the tamponade), the internal limiting membrane (the innermost layer of the retina) is either peeled as well or left untouched and the question which method should be preferred has been a hot topic in recent years. The investigators want to investigate possible effects of the used method (peeling vs. nonpeeling) on retinal perfusion parameters represented by OCTA. Two epiretinal membrane patient groups will therefore be formed: The first group's (group 1) ILM will be peeled, the second group's (group 2) ILM will not be peeled. After recruitement, patients will therefore be electronically randomized to one of the two groups. The groups will then be compared by the means of OCTA.
Study design
Since there are no previous data on our research question, this investigation is defined as a pilot study.
40 patients with epiretinal membranes will be included. This appears to be a reasonable number given the incidence of epiretinal membranes. Previous studies that compared peeling versus nonpeeling in ERM used similar sample sizes. The detectable effect size was calculated at d = 0.91. We intend to complete this pilot study within 9 months.
Randomization will be performed using electronic randomization. 20 patients each will be randomized to either group 1 or group 2.
Both eyes in each patient will be imaged.
No treatment decisions will be made based on OCTA findings. Treatment decisions will be made according to the clinic's standard of care.
Three follow-up visits specific to the study are needed. These visits will be scheduled one week, one month and three months after surgery. All other preoperative and follow-up visits will be decided by the treating physician and follow the clinic standard of care.
Examinations
Distance visual acuity using ETDRS (Early Treatment Diabetic Retinopathy Study) standard at 4 meters as per clinic standard of care.
Tonometry as per clinic standard of care.
Slit-lamp evaluation as per clinic standard of care.
Arterial blood pressure.
Axial eye length.
Heidelberg Spectralis conventional OCT.
The following 2 AngioVue scans will be taken:
A. One 3mm x 3mm, 304 x 304 A-scan OCTA of the macula B. One 6mm x 6mm, 304 x 304 A-scan OCTA of the macula
Hypothesis
The null hypothesis of our investigation indicates that there are no statistically significant differences in OCTA perfusion parameters based on the used option.
The alternative hypothesis states that there are statistically significant differences in OCTA perfusion parameters based on the used option.
Primary Objective
To demonstrate possible differences in OCTA perfusion parameters based on the used option.
Secondary Objectives
To assess the feasibility of the AngioVue optical coherence tomography angiography system in evaluating subtle changes in the retinal perfusion of patients with epiretinal membranes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane of Both Eyes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ILM nonpeeling
Arm Type
Experimental
Arm Title
ILM peeling
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
ILM nonpeeling
Intervention Description
ILM is not peeled after ERM removal
Intervention Type
Procedure
Intervention Name(s)
ILM peeling
Intervention Description
ILM is peeled after ERM removal
Primary Outcome Measure Information:
Title
Superficial capillary plexus foveal avascular zone area
Description
Superficial capillary plexus foveal avascular zone area (SCP FAZ) change (preoperative to postoperative). The SCP FAZ represents the area of the macula where blood vessels are not seen in OCTA under physiologic conditions. It has previously been reported that the FAZ narrows during ERM development and enlarges after ERM removal.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be able and willing to give informed consent.
Patient must be over 18 and below 100 years of age.
Patient must not have any significant media opacity which interferes with the examination.
Patient must have an epiretinal membrane requiring surgery.
Exclusion Criteria:
Unwilling or unable to provide informed consent
Under 18 or over 100 years of age
Significant media opacities
Systemic pathologies making an examination difficult or cumbersome to the patient
Secondary epiretinal membranes
Bilateral epiretinal membranes
Macular holes
Lamellar holes
Pseudo holes
Glaucoma
Diabetes
Anisometropia > 2 diopters
High myopia (spherical equivalent > 6 diopters and/or axial length > 26 mm
Other retinal or ophthalmic pathologies except moderate cataract
OCTA scan signal strength < 50
Low image quality
Failure of automatic layer segmentation
Facility Information:
Facility Name
Medical University Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35976252
Citation
Gabriel M, Djavid D, Innauer F, Ivastinovic D, Seidel G, Mayer-Xanthaki C, Ansari-Shahrezaei S, Wedrich A, Haas A. CHANGES OF OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY PARAMETERS AFTER INTERNAL LIMITING MEMBRANE PEELING COMPARED WITH NONPEELING IN EPIRETINAL MEMBRANE SURGERY. Retina. 2022 Oct 1;42(10):1867-1873. doi: 10.1097/IAE.0000000000003567.
Results Reference
derived
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Optical Coherence Tomography Angiography (OCTA) Changes in Patients With Epiretinal Membranes (ERM) With and Without Peeling of the Internal Limiting Membrane (ILM)
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