The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jin Chen-jin，Sun Yat-sen University

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 31, 2016

Estimated Primary Completion Date

October 10, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes of retinal capillaries after hd-PDT[ Time Frame: 1 month, 3 month ]

The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

The proportion of eyes with complete absorption of subretinal fluid(SRF)[ Time Frame: 1 month, 3 month ]
The outcome 2 measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
Change of Best Corrected Visual Acuity(BCVA)[ Time Frame: 1 month, 3 month ]
The outcome 3 measure is the EDTRS charts-based improvement of Best Corrected Visual Acuity
Changes of choroidal thickness after hd-PDT[ Time Frame: 1 month, 3 month ]
The outcome 4 measure is the OCT-based thinning of choroidal thickness after hd-PDT

Descriptive Information

Brief Title ^ICMJE

The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC

Official Title ^ICMJE

The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy

Brief Summary

To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC).

Detailed Description

PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of studies have reported choriocapillary damage and choroidal vascular remodeling after PDT. More recently, although OCTA related CSC research has been conducted, no quantitative report has thoroughly investigated the microstructural changes in the superficial, deep retinal and choroidal capillaries after hd-PDT. The purpose of the present study is to determine the changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in eyes with CSC. This is a prospective observational study of patients undergoing hd-PDT for CSC with active leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up visit after hd-PDT.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Half-dose photodynamic therapy
Half-dose photodynamic therapy was achieved by administering 3mg/m² of Verteporfin (Visudyne; Novartis, Switzerland) intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the greatest linear dimension was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². Optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.

Study Arms

: CSC patients
Half-dose photodynamic therapy was performed when a serous retinal detachment involving the macular fovea was present; The treatment field size was set as 3000 microns. This was achieved by administering 3mg/m² of Verteporfin intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the GLD was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². OCTA (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2019

Estimated Primary Completion Date

October 10, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: 1. CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT 2. Patient age ≥18 years 3. BCVA ≥35 letters on ETDRS charts 4. Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment 5. Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug 6. The provision of written informed consent - Exclusion Criteria: 1. The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV) 2. Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC 3. Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns 4. Patients with high myopia, defined as a refractive error (spherical equivalent) < -6.00 diopters, or an axial length >26.5 mm 5. Patients with media opacities, or signal strength index of the images < 60 6. Patients under corticosteroid therapy -

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Jin Chen-jin，Sun Yat-sen University

Study Sponsor ^ICMJE

Jin Chen-jin

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Chenjin Jin Zhongshan Ophthalmic Center, Sun Yat-sen University

PRS Account

Sun Yat-sen University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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