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Effects of OCTA-guided PDT in Acute CSC

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: NCT03497000
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Mingwei Zhao, Peking University People's Hospital

Study Description
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Brief Summary:
OCTA-guided PDT is as safe and effective as ICGA-guided PDT in the treatment of acute central serous chorioretinopathy. Or OCTA-guided PDT is more effective than ICGA-guided PDT in the treatment of acute central serous chorioretinopathy, safe as well.

Condition or disease Intervention/treatment Phase
Central Serous Chorioretinopathy Tomography, Optical Coherence Procedure: OCTA-guided Photodynamic therapy Procedure: ICGA-guided Photodynamic therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : March 27, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: OCTA group
Patients in this group underwent OCTA-guided half-dose photodynamic therapy.
 Procedure: OCTA-guided Photodynamic therapy
Half-dose photodynamic therapy using verteporfin under the guidance of OCTA
Active Comparator: ICGA group
Patients in this group underwent normal ICGA-guided half dose photodynamic therapy.
 Procedure: ICGA-guided Photodynamic therapy
Half-dose photodynamic therapy using verteporfin under the guidance of ICGA


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with subretinal fluid resolution on OCT after PDT of two groups [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Number of patients with leakage point resolution on FFA after PDT of two groups [ Time Frame: 3 months ]
  2. Number of recurrent CSC after PDT of two groups [ Time Frame: 3 months ]
  3. BCVA (best corrected visual acuity) at every follow-up of two groups [ Time Frame: 1 month, 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
  • Presence of SRF and/or serous pigment epithelial detachment on OCT
  • Presence of abnormal dilated choroidal vasculature in ICGA

Exclusion Criteria:

  • Patients with other ocular conditions commonly associated with SRF, such as choroidal neovascularization, polypoidal choroidal vasculopathy (PCV), diabetic retinopathy, retinal vascular occlusion, Coat's disease
  • Any disease that may affect the quality of imaging (quality of OCTA images < 6), such as cataract, high myopia or nystagmus
  • History of ocular surgeries including retinal laser
  • Pregnancy
  • Any uncontrolled systemic disease
  • Any condition rendering patients intolerable to image acquisition
Contacts and Locations
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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): NCT03497000


Locations
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China, Beijing
People's Hospital of Peking University
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
National Natural Science Foundation of China
Investigators
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Study Director: Mingwei Zhao, M.D Peking University People's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mingwei Zhao, Head of Ophthalmology, Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03497000    
Other Study ID Numbers: Peking UPH
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mingwei Zhao, Peking University People's Hospital:
optical coherence tomography angiography
central serous chorioretinopathy
photodynamic therapy
Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases