Eye Patch Therapy for Central Serous Retinopathy (CSR)

Central Serous Retinopathy (CSR) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036632
• Other study ID #: 201211016
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2014
• Last updated: June 1, 2015
• Start date: November 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Washington University School of Medicine
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Central Serous Retinopathy (CSR)
• Retinal Diseases

Intervention

Device:
• Eye Patching

Locations

Country	Name	City	State
United States	Washington Universtiy School of Medicine	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change in multi-focal ERG response		24 hours	No
Secondary	macular thickness		24 hours	No