Eye Patch Therapy for Central Serous Retinopathy (CSR)

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT02036632
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 26
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Serous Retinopathy (CSR)	Device: Eye Patching	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Eye Patching as a Potential Treatment Modality for and a Possible Etiological Insight on Central Serous Retinopathy
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Eye Patching Intervention	Device: Eye Patching

Outcome Measures

Primary Outcome Measures

1. Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR [24 hours]

   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).

2. Change in multi-focal ERG response [24 hours]

Secondary Outcome Measures

1. macular thickness [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington Universtiy School of Medicine	St Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Gregory P Van Stavern, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT02036632
• Other Study ID Numbers: 201211016
• First Posted: Jan 15, 2014
• Last Update Posted: Jun 3, 2015
• Last Verified: Jun 1, 2015

• Additional relevant MeSH terms: Retinal Diseases; Central Serous Chorioretinopathy

Study Results

No Results Posted as of Jun 3, 2015