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Eye Patch Therapy for Central Serous Retinopathy (CSR)

Primary Purpose

Central Serous Retinopathy (CSR)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Eye Patching

About this trial

This is an interventional supportive care trial for Central Serous Retinopathy (CSR)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Washington Universtiy School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Eye Patching

Arm Description

Intervention

Outcomes

Primary Outcome Measures

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).

Change in multi-focal ERG response

Secondary Outcome Measures

macular thickness

Full Information

NCT ID

NCT02036632

First Posted

January 8, 2014

Last Updated

June 1, 2015

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02036632

Brief Title

Eye Patch Therapy for Central Serous Retinopathy (CSR)

Official Title

Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Serous Retinopathy (CSR)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Eye Patching

Arm Type

Other

Arm Description

Intervention

Intervention Type

Device

Intervention Name(s)

Eye Patching

Primary Outcome Measure Information:

Title

Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR

Description

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).

Time Frame

24 hours

Title

Change in multi-focal ERG response

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

macular thickness

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory P Van Stavern, MD

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington Universtiy School of Medicine

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Eye Patch Therapy for Central Serous Retinopathy (CSR)

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