Quantification of Metamorphopsia in Patients With Epireti... | NCT05138315

Studies
Quantification of Metamorphopsia in Patients With Epiretinal Membranes

NCT05138315

Sponsor

Vienna Institute for Research in Ocular Surgery

Status

Unknown status

Last Update Posted

Dec 15, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

Metamorphopsia quantification

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2021Actual

Primary Completion Date

Nov 30, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Nov 16, 2021

First Submission Date that Met QC Criteria

Nov 16, 2021

First Posted Date

Nov 30, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2021

Last Update Posted Date

Dec 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prim. Prof. Dr. Oliver Findl, MBA, Prof., MD, MBA, Vienna Institute for Research in Ocular SurgeryPrincipal Investigator

Lead Sponsor

Vienna Institute for Research in Ocular SurgeryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental	Alleye App and M-chart examinations will be performed pre- and postsurgically.	Device: Metamorphopsia quantification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metamorphopsia quantification	Device	Alleye App and M.chart examinations will be performed pre- and postsurgically.	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oliver Findl, Prof.	Contact	+43 1 91021 84611		oliver.findl@oegk.at
Christoph Leisser, MD	Contact	+43 1 91021 84611		christoph.leisser@oegk.at

Overall Officials

Name	Affiliation	Role
Oliver Findl, Prof.	head of department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Recruiting	Vienna		1140	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40245427	Derived	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.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases