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Eye Patch Therapy for Central Serous Retinopathy (CSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02036632
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Eye Patching
Intervention
Device: Eye Patching



Primary Outcome Measures :
  1. Change in multi-focal ERG response and macular thickness after 24-hour patch therapy in patients with CSR [ Time Frame: 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 [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. macular thickness [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036632


Locations
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United States, Missouri
Washington Universtiy School of Medicine
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Gregory P Van Stavern, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02036632    
Other Study ID Numbers: 201211016
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Retinal Diseases
Central Serous Chorioretinopathy
Eye Diseases