Eye Patch Therapy for Central Serous Retinopathy (CSR) | NCT02036632

Studies
Eye Patch Therapy for Central Serous Retinopathy (CSR)

NCT02036632

Sponsor

Washington University School of Medicine

Status

Completed

Last Update Posted

Jun 3, 2015Estimated

Enrollment

12Estimated

Phase

Phase 1

Conditions

Central Serous Retinopathy (CSR)

Interventions

Eye Patching

Countries

United States

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Jan 13, 2014

First Posted Date

Jan 15, 2014Estimated

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

Jun 1, 2015

Last Update Posted Date

Jun 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.

Detailed Description

Not provided

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eye Patching	Other	Intervention	Device: Eye Patching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eye Patching	Device		Eye Patching

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR	This study is a prospective control trial that will compare 24-hour eye patch therapy with the current standard of care in patients with central serous retinopathy (CSR).	24 hours
Change in multi-focal ERG response		24 hours

Secondary Outcomes

Measure	Description	Time Frame
macular thickness		24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults 18 years of age and older
Both males and females
Patients diagnosed with active central serous retinopathy
Patients who are willing to use an eye patch in the affected eye for 24 hours
Patients who are able to make the follow up appointments as required by the study

Exclusion Criteria:

Individuals under 18 years of age
Patients with vision less than 20/40 in the unaffected eye.
Patients who are not able to undergo mfERG testing in a realiable manner.

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

Not provided

Overall Officials

Name	Affiliation	Role
Gregory P Van Stavern, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington Universtiy School of Medicine		St Louis	Missouri	63110	United States

Condition Browse Module

MeSH Terms

ID	Term
D056833	Central Serous Chorioretinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided