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Effects of OCTA-guided PDT in Acute CSC

Sponsor
Peking University People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03497000
Collaborator
National Natural Science Foundation of China (Other)
23
Enrollment
1
Location
2
Arms
6.8
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: OCTA-guided Photodynamic therapy
  • Procedure: ICGA-guided Photodynamic therapy
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2017
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Mar 27, 2018

Arms and Interventions

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

Primary Outcome Measures

  1. Number of patients with subretinal fluid resolution on OCT after PDT of two groups [3 months]

Secondary Outcome Measures

  1. Number of patients with leakage point resolution on FFA after PDT of two groups [3 months]

  2. Number of recurrent CSC after PDT of two groups [3 months]

  3. BCVA (best corrected visual acuity) at every follow-up of two groups [1 month, 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

  • Study Director: Mingwei Zhao, M.D, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Apr 12, 2018
Last Update Posted:
Apr 17, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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, Head of Ophthalmology, Professor, Peking University People's Hospital
optical coherence tomography angiography
central serous chorioretinopathy
photodynamic therapy
Additional relevant MeSH terms:
Central Serous Chorioretinopathy

Study Results

No Results Posted as of Apr 17, 2018