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

NCT03692169 | Unknown FDA Device

• 1 other identifier: CSC-PDT-OCTA（ZOC）
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

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).

Conditions

Central Serous Chorioretinopathy

Keywords

Central serous chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• Changes of retinal capillaries after hd-PDT

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

  1 month, 3 month

Secondary Outcomes (3)

• The proportion of eyes with complete absorption of subretinal fluid(SRF)

  1 month, 3 month

• Change of Best Corrected Visual Acuity(BCVA)

  1 month, 3 month

• Changes of choroidal thickness after hd-PDT

  1 month, 3 month

Study Arms (1)

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.

Procedure: Half-dose photodynamic therapy

Interventions

Half-dose photodynamic therapy PROCEDURE

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.

CSC patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Central Serous Chorioretinopathy (CSC)

You may qualify if:

• CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT
• Patient age ≥18 years
• BCVA ≥35 letters on ETDRS charts
• Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment
• Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug
• The provision of written informed consent -

You may not qualify if:

• The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)
• Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC
• Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns
• Patients with high myopia, defined as a refractive error (spherical equivalent) \< -6.00 diopters, or an axial length \>26.5 mm
• Patients with media opacities, or signal strength index of the images \< 60
• Patients under corticosteroid therapy -

Sponsors & Collaborators

• Jin Chen-jin: lead

Study Sites (2)

Fabao Xu

Guangzhou, Guangdong, 510000, China

COMPLETED

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

• Peng J, Zhong L, Ma L, Jin J, Zheng Y, Jin C. Comparison of vascular parameters between normal cynomolgus macaques and healthy humans by optical coherence tomography angiography. BMC Ophthalmol. 2019 Oct 11;19(1):204. doi: 10.1186/s12886-019-1207-x.

  PMID: 31601186 DERIVED

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Chenjin Jin

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Fabao Xu

CONTACT

15521250400; 517311823@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jin Chen-jin

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: October 2, 2018
• Study Start: October 31, 2016
• Primary Completion: October 10, 2018
• Study Completion: June 30, 2019
• Last Updated: October 2, 2018

Record last verified: 2018-09

Locations

CN (2)