Quantification of Metamorphopsia in Patients With Epiretinal Membranes

Not Applicable

• Conditions: Epiretinal Membrane
• Interventions: Device: Metamorphopsia quantification

• Registration Number: NCT05138315
• Lead Sponsor: Vienna Institute for Research in Ocular Surgery

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.

Study Timeline

• Status Verified: 2021-11
• Study Start: 2021-11-16
• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-30
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-15
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	Metamorphopsia quantification	Alleye App and M-chart examinations will be performed pre- and postsurgically.

Primary Outcome Measures

Name	Time	Method
M-chart Scores (horizontal and vertical)	5 minutes	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
Alleye App Score	5 minutes	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

Trial Locations

Locations (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna; 🇦🇹 Vienna, Austria