search
Back to results

Effects of OCTA-guided PDT in Acute CSC

Primary Purpose

Central Serous Chorioretinopathy, Tomography, Optical Coherence

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OCTA-guided Photodynamic therapy
ICGA-guided Photodynamic therapy
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring optical coherence tomography angiography, central serous chorioretinopathy, photodynamic therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • People's Hospital of Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OCTA group

ICGA group

Arm Description

Patients in this group underwent OCTA-guided half-dose photodynamic therapy.

Patients in this group underwent normal ICGA-guided half dose photodynamic therapy.

Outcomes

Primary Outcome Measures

Number of patients with subretinal fluid resolution on OCT after PDT of two groups

Secondary Outcome Measures

Number of patients with leakage point resolution on FFA after PDT of two groups
Number of recurrent CSC after PDT of two groups
BCVA (best corrected visual acuity) at every follow-up of two groups

Full Information

First Posted
March 28, 2018
Last Updated
April 14, 2018
Sponsor
Peking University People's Hospital
Collaborators
National Natural Science Foundation of China
search

1. Study Identification

Unique Protocol Identification Number
NCT03497000
Brief Title
Effects of OCTA-guided PDT in Acute CSC
Official Title
Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
National Natural Science Foundation of China

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy, Tomography, Optical Coherence
Keywords
optical coherence tomography angiography, central serous chorioretinopathy, photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCTA group
Arm Type
Experimental
Arm Description
Patients in this group underwent OCTA-guided half-dose photodynamic therapy.
Arm Title
ICGA group
Arm Type
Active Comparator
Arm Description
Patients in this group underwent normal ICGA-guided half dose photodynamic therapy.
Intervention Type
Procedure
Intervention Name(s)
OCTA-guided Photodynamic therapy
Intervention Description
Half-dose photodynamic therapy using verteporfin under the guidance of OCTA
Intervention Type
Procedure
Intervention Name(s)
ICGA-guided Photodynamic therapy
Intervention Description
Half-dose photodynamic therapy using verteporfin under the guidance of ICGA
Primary Outcome Measure Information:
Title
Number of patients with subretinal fluid resolution on OCT after PDT of two groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of patients with leakage point resolution on FFA after PDT of two groups
Time Frame
3 months
Title
Number of recurrent CSC after PDT of two groups
Time Frame
3 months
Title
BCVA (best corrected visual acuity) at every follow-up of two groups
Time Frame
1 month, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingwei Zhao, M.D
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
People's Hospital of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32343102
Citation
Hu J, Qu J, Li M, Sun G, Piao Z, Liang Z, Yao Y, Sadda S, Zhao M. OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY-GUIDED PHOTODYNAMIC THERAPY FOR ACUTE CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2021 Jan 1;41(1):189-198. doi: 10.1097/IAE.0000000000002795.
Results Reference
derived

Learn more about this trial

Effects of OCTA-guided PDT in Acute CSC

We'll reach out to this number within 24 hrs