Quantification of Metamorphopsia in Patients With Epiretinal Membranes

NCT ID: NCT05138315

Last Updated: 2021-12-15

Basic Information

• 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

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.

Conditions

Epiretinal Membrane

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Metamorphopsia quantification

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Prof., MD, MBA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, Prof.

Role: PRINCIPAL_INVESTIGATOR

head of department

Locations

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

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Oliver Findl, Prof.

Role: CONTACT

oliver.findl@oegk.at

+43 1 91021 84611

Christoph Leisser, MD

Role: CONTACT

christoph.leisser@oegk.at

+43 1 91021 84611

Facility Contacts

Oliver Findl, MD, MBA

Role: primary

References

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

AEM

Identifier Type: -

Identifier Source: org_study_id