Quantification of Metamorphopsia in Patients With Epiretinal Membranes

NCT05138315 | Unknown

• 1 other identifier: AEM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiretinal Membrane

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Study Group

EXPERIMENTAL

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

Device: Metamorphopsia quantification

Interventions

Metamorphopsia quantification DEVICE

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

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

Vienna, 1140, Austria

RECRUITING

Related Publications (1)

• 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.

  PMID: 40245427 DERIVED

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Oliver Findl, Prof.

  head of department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Findl, Prof.

CONTACT

+43 1 91021 84611; oliver.findl@oegk.at

Christoph Leisser, MD

CONTACT

+43 1 91021 84611; christoph.leisser@oegk.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., MD, MBA

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: November 16, 2021
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-11

Locations

AU (1)