Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

NCT05589974 | Recruiting

• 1 other identifier: REK485079
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (2)

• Change in mean blur rate

  Relative changes in choroidal blood flow

  6 months

• Change in pulse wave form analysis

  Changes in the shapes of pulse curves

  6 months

Secondary Outcomes (2)

• Change in choroidal density

  6 months

• Change in choroidal thickness

  6 months

Study Arms (2)

Acute

Patients with acute first attack CSC with subretinal fluid (SRF) on OCT and symptom duration under 4 months.

Chronic

Patients with chronic CSC, i.e. symptoms and SRF for more than 4 months.

Drug: Verteporfin

Interventions

Verteporfin DRUG

Chronic CSC are receiving one treatment before the observation period.

Chronic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with acute or chronic CSC.

You may qualify if:

• Able to sign informed consent
• Possible to obtain fundus imaging
• Acute CSC ˂4 months of duration in one eye, defined as:
• Subfoveal presence of SRF on OCT
• 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:
• Subfoveal presence of SRF on OCT
• Subjective visual loss/symptoms
• Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT
• Patient history and examination consistent with chronic CSC

You may not qualify if:

• History of retinal disease other than CSC (e.g. retinal detachment)
• Contraindications for FA, ICGA or PDT (only for chronic CSC)

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital, Department of Ophthalmology

Stavanger, 4016, Norway

RECRUITING

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

Verteporfin

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Vegard Forsaa, MD PhD

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vegard Forsaa, MD PhD

CONTACT

+4748152212; forsaa@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 21, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

NO (1)