Quantification of Metamorphopsia in Patients With Epiretinal Membranes
Primary Purpose
Epiretinal Membrane
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Metamorphopsia quantification
Sponsored by
About this trial
This is an interventional diagnostic trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- Idiopathic ERM
- Sheduled surgery (vitrectomy with membrane peeling)
- Age 18 and older
- Written informed consent for participation in the study
- Metamorphopsia detected by the Amsler grid
- BCVA ≥ 0,1
Exclusion Criteria:
- Secondary ERM due to retinal tears, retinal detachment, retinal vascular diseases and uveitis
- Other macular disorders including AMD
- Previous intraocular surgery except for uncomplicated cataract surgery
- Pregnancy (pregnancy test will be performed in women of reproductive age)
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital ViennaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Alleye App and M-chart examinations will be performed pre- and postsurgically.
Outcomes
Primary Outcome Measures
Alleye App Score
The Alleye App measures the degree of metamorphopsia, the range of the Alleye App Score: 0 to 100 points, with 100 being the best achievable result, while lower values are associated with increasing degree of metamorphopsia
M-chart Scores (horizontal and vertical)
The M-charts measure the degree of horizontal and vertical metamorphopsia, the range of M-charts: 0 to 2.0, with higher values indicating a higher degree of metamorphopsia
Secondary Outcome Measures
Full Information
NCT ID
NCT05138315
First Posted
November 16, 2021
Last Updated
November 30, 2021
Sponsor
Vienna Institute for Research in Ocular Surgery
1. Study Identification
Unique Protocol Identification Number
NCT05138315
Brief Title
Quantification of Metamorphopsia in Patients With Epiretinal Membranes
Official Title
Quantification of Metamorphopsia Using the Alleye App Compared to the M-chart in Patients With Epiretinal Membranes a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of this study is to examine metamorphopsia before and 3 months after vitrectomy with membrane peeling among patients with idiopathic epiretinal membranes. Therefore, the correlation between the Alleye App and the M-chart test before and after ERM surgery and the associations of OCT biomarkers to postsurgical changes in metamorphopsia scores will be examined.
Detailed Description
Epiretinal membranes are common disorders leading to visual loss and metamorphopsia in later stages. In most cases they are idiopathic with no identifiable cause (iERM). ERM can be visualized with optical coherence tomography (OCT) and can cause metamorphopsia, usually diagnosed with the Amsler grid or metamorphopsia chart (M-chart), which have influence on vision. ERM are surgically treated by vitrectomy and membrane peeling, however, postoperative visual acuity and quality of vision are difficult to predict. Quality of vision is highly dependent on metamorphopsia which can be an overlooked symptom. Thus, detailed examinations using M-charts prior to surgery can help to quantify the degree of metamorphopsia and might predict the potential benefit of the surgery. Recently, home monitoring tests for metamorphopsia using handheld mobile devices are becoming increasingly important. The Alleye App is one of two m-health applications with FDA approval, that is already in use for monitoring the progression of metamorphopsia in other retinal diseases such as age-related macular degeneration (AMD). It has yet to be evaluated for ERM. Aim of this study is to examine the correlation between the Alleye App and the M-chart test before and after ERM surgery and the associations of OCT biomarkers to postsurgical changes in metamorphopsia scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
Alleye App and M-chart examinations will be performed pre- and postsurgically.
Intervention Type
Device
Intervention Name(s)
Metamorphopsia quantification
Intervention Description
Alleye App and M.chart examinations will be performed pre- and postsurgically.
Primary Outcome Measure Information:
Title
Alleye App Score
Description
The Alleye App measures the degree of metamorphopsia, the range of the Alleye App Score: 0 to 100 points, with 100 being the best achievable result, while lower values are associated with increasing degree of metamorphopsia
Time Frame
5 minutes
Title
M-chart Scores (horizontal and vertical)
Description
The M-charts measure the degree of horizontal and vertical metamorphopsia, the range of M-charts: 0 to 2.0, with higher values indicating a higher degree of metamorphopsia
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic ERM
Sheduled surgery (vitrectomy with membrane peeling)
Age 18 and older
Written informed consent for participation in the study
Metamorphopsia detected by the Amsler grid
BCVA ≥ 0,1
Exclusion Criteria:
Secondary ERM due to retinal tears, retinal detachment, retinal vascular diseases and uveitis
Other macular disorders including AMD
Previous intraocular surgery except for uncomplicated cataract surgery
Pregnancy (pregnancy test will be performed in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver Findl, Prof.
Phone
+43 1 91021 84611
Email
oliver.findl@oegk.at
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Leisser, MD
Phone
+43 1 91021 84611
Email
christoph.leisser@oegk.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, Prof.
Organizational Affiliation
head of department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD, MBA
12. IPD Sharing Statement
Learn more about this trial
Quantification of Metamorphopsia in Patients With Epiretinal Membranes
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