Quantification of Metamorphopsia in Patients With Epiretinal Membranes

Epiretinal Membrane Clinical Trial

Official title:

Quantification of Metamorphopsia Using the Alleye App Compared to the M-chart in Patients With Epiretinal Membranes a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05138315
• Other study ID #: AEM
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Oliver Findl, Prof.
• Phone: +43 1 91021 84611
• Email: oliver.findl[@]oegk.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epiretinal Membrane
• Vision Disorders

Intervention

Device:
• Metamorphopsia quantification
Alleye App and M.chart examinations will be performed pre- and postsurgically.

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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