Effects of OCTA-guided PDT in Acute CSC

April 14, 2018 updated by: Mingwei Zhao, Peking University People's Hospital

Effects of Optical Coherence Tomography Angiography-guided Photodynamic Therapy in Acute Central Serous Chorioretinopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • People's Hospital of Peking University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with subretinal fluid resolution on OCT after PDT of two groups
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

National Natural Science Foundation of China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 27, 2018

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 14, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peking UPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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