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Quantification of Metamorphopsia in Patients With Epiretinal Membranes

NCT ID: NCT05138315

Last Updated: 2021-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-16

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Epiretinal Membrane

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

Alleye App and M-chart examinations will be performed pre- and postsurgically.

Group Type EXPERIMENTAL

Metamorphopsia quantification

Intervention Type DEVICE

Alleye App and M.chart examinations will be performed pre- and postsurgically.

Interventions

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Metamorphopsia quantification

Alleye App and M.chart examinations will be performed pre- and postsurgically.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Prof., MD, MBA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Findl, Prof.

Role: PRINCIPAL_INVESTIGATOR

head of department

Locations

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Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Oliver Findl, Prof.

Role: CONTACT

Phone: +43 1 91021 84611

Email: [email protected]

Christoph Leisser, MD

Role: CONTACT

Phone: +43 1 91021 84611

Email: [email protected]

Facility Contacts

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Oliver Findl, MD, MBA

Role: primary

References

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Amon D, Leisser C, Schlatter A, Ruiss M, Pilwachs C, Bayer N, Huemer J, Findl O. Quantification of Metamorphopsia Using a Smartphone-Based Hyperacuity Test in Patients With Idiopathic Epiretinal Membranes: Prospective Observational Study. JMIR Perioper Med. 2025 Apr 17;8:e60959. doi: 10.2196/60959.

Reference Type DERIVED
PMID: 40245427 (View on PubMed)

Other Identifiers

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AEM

Identifier Type: -

Identifier Source: org_study_id