NCT03692169

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Jin Chen-jin · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Conditions

• Central Serous Chorioretinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-31
• Primary completion: 2018-10-10
• Completion: 2019-06-30
• First posted: 2018-10-02
• Last updated: 2018-10-02

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated device study