Quantification of Metamorphopsia in Patients With Epiretinal Membranes

Quantification of Metamorphopsia Using the Alleye App Compared to the M-chart in Patients With Epiretinal Membranes a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Epiretinal Membrane
• Intervention / Treatment: Device: Metamorphopsia quantification

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oliver Findl, Prof.; Phone Number: +43 1 91021 84611; Email: oliver.findl@oegk.at
• Study Contact Backup: Name: Christoph Leisser, MD; Phone Number: +43 1 91021 84611; Email: christoph.leisser@oegk.at

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Recruiting
    • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
    • Contact: Oliver Findl, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Alleye App and M-chart examinations will be performed pre- and postsurgically.	Device: Metamorphopsia quantification; Alleye App and M.chart examinations will be performed pre- and postsurgically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 minutes
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	5 minutes

Collaborators and Investigators

• Sponsor: Vienna Institute for Research in Ocular Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Retinal Diseases; Sensation Disorders; Vision Disorders; Epiretinal Membrane
• Other Study ID Numbers: AEM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No