Aniseikonia in Epiretinal Membrane Patients | NCT03661593

Studies
Aniseikonia in Epiretinal Membrane Patients

NCT03661593

Sponsor

Glostrup University Hospital, Copenhagen

Status

Unknown status

Last Update Posted

Sep 7, 2018Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Epiretinal Membrane

Interventions

Cataract guideline

Countries

Denmark

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

Sep 2018

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 1, 2017Actual

Primary Completion Date

Jan 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Aug 31, 2018

First Submission Date that Met QC Criteria

Sep 5, 2018

First Posted Date

Sep 7, 2018Actual

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

Sep 5, 2018

Last Update Posted Date

Sep 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Therese Krarup, Principal investigator, Glostrup University Hospital, CopenhagenPrincipal Investigator

Lead Sponsor

Glostrup University Hospital, CopenhagenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Examination of aniseikonia in epiretinal membranes patients before and after surgery

Detailed Description

Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cataract guideline	Experimental	In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery	Other: Cataract guideline
Standard refraction	No Intervention	The patients gets an IOL ensuring his preoperatively refraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cataract guideline	Other	The patients gets an IOL according to cataract guideline correcting the ametropia	Cataract guideline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aniseikonia	Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Epiretinal membrane Phakic on both eyes

Exclusion Criteria:

no previous eye surgeries
refractive status +/- 2 seq

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye department, Nordre ringvej 56	Recruiting	Copenhagen	Glostrup	2600	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

No planing on sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019773	Epiretinal Membrane

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided