CClinicalTrials.gg
Status unknownNCT05138315Updated Dec 15, 2021

Quantification of Metamorphopsia in Patients With Epiretinal Membranes

An interventional study of Metamorphopsia quantification in Epiretinal Membrane, sponsored by Vienna Institute for Research in Ocular Surgery. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-15.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epiretinal Membrane
03

In context

Vision Disorders

308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 211 interventional studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Vienna Institute for Research in Ocular Surgery is the lead sponsor of 64 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Study Group

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

    Device: Metamorphopsia quantification

Interventions

  • DeviceMetamorphopsia quantification

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 minutes

  2. 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

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
  • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
    Vienna, 1140, Austria
    • Oliver Findl, MD, MBA · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05138315
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Prof., MD, MBA, Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Nov 30, 2021
Start date
Nov 16, 2021
Primary completion
Nov 30, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Dec 15, 2021

Study contacts

Oliver Findl, Prof.
Contact
oliver.findl@oegk.at
+43 1 91021 84611
Christoph Leisser, MD
Contact
christoph.leisser@oegk.at
+43 1 91021 84611
Oliver Findl, Prof.
principal investigator · head of department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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