Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

Official title:

Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05589974
• Other study ID #: REK485079
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: July 31, 2026

Study information

• Verified date: November 2023
• Source: Helse Stavanger HF
• Contact: Vegard Forsaa, MD PhD
• Phone: +4748152212
• Email: forsaa[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.

Description:

Acute CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. Such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity.

Chronic CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with PDT. The research of such changes will increase the understanding of the treatment response. This knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:-

• Able to sign informed consent

• Possible to obtain fundus imaging

• Acute CSC ?4 months of duration in one eye, defined as:

1. Subfoveal presence of SRF on OCT

2. Present attack is 1st -3rd attack of CSC

b) Patient history and examination consistent with acute CSC c) Characteristic appearance of acute CSC on fundus autofluorescence (FAF) and OCT

• Chronic CSC =4 months of duration in one eye, defined as:

1. Subfoveal presence of SRF on OCT

2. Subjective visual loss/symptoms

3. Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT

4. Patient history and examination consistent with chronic CSC

Exclusion Criteria:

• History of retinal disease other than CSC (e.g. retinal detachment)

• Contraindications for FA, ICGA or PDT (only for chronic CSC)

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• Verteporfin
Chronic CSC are receiving one treatment before the observation period.

Locations

Country	Name	City	State
Norway	Stavanger University Hospital, Department of Ophthalmology	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean blur rate	Relative changes in choroidal blood flow	6 months
Primary	Change in pulse wave form analysis	Changes in the shapes of pulse curves	6 months
Secondary	Change in choroidal density	Changes in the tissue density	6 months
Secondary	Change in choroidal thickness	Changes in the morphology of the choroid	6 months