Pseudo-PDT in Central Serous Chorioretinopathy

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Brief Title

Pseudo-PDT in Central Serous Chorioretinopathy


Brief Summary

      Acute central serous chorioretinopathy (CSC) is a common disorder in middle-aged patients,
      characterized by serous retinal detachment in the macular region. We evaluated half-dose
      verteporfin photodynamic therapy (hd-PDT) versus 689 nm laser treatment in chronic CSC.

      Twenty-two eyes of 22 patients with symptomatic chronic CSC were randomized in a 1:1 ratio to
      receive hd-PDT (group 1) or 689-LT delivering 95 J/cm2 by application of an intensity of 805
      mW/cm2 over 118 seconds. Best-corrected visual acuity (BCVA) and spectral-domain optical
      coherence tomography findings were compared between groups.
    



Study Type

Interventional


Primary Outcome

Best-corrected Visual Acuity (LogMAR)

Secondary Outcome

 Ellipsoid Zone Recovery (integrity of IS/OS line)

Condition

Chronic Central Serous Chorioretinopathy

Intervention

689 nm Laser Treatment of the Macula

Study Arms / Comparison Groups

 Half Dose Photodynamic Therapy
Description:  Half Dose Photodynamic Therapy The safety enhanced PDT protocol for CSC was performed using half the normal dose of verteporfin (Visudyne, Novartis Pharma, Switzerland), which is 3 mg/m2 verteporfin

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

22

Start Date

June 2016

Completion Date

September 2016

Primary Completion Date

September 2016

Eligibility Criteria

        Inclusion Criteria:

          -  age ≥18 years;

          -  patients with best-corrected visual acuity (BCVA) of 20/200 or better;

          -  presence of subretinal fluid (SRF) and/or serous pigment epithelial detachment
             involving the fovea on optical coherence tomography (OCT);

          -  presence of active angiographic leakage in fluorescein angiography caused by CSC and
             no other diseases, and abnormal dilated choroidal vasculature and other features in
             indocyanine green angiography (ICGA) consistent with the diagnosis of CSC.

        Exclusion Criteria:

          -  any previous treatment for CSC;

          -  evidence of choroidal neovascularization or other maculopathy on fundus examination.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +390303995308, [email protected]



Administrative Informations


NCT ID

NCT02799992

Organization ID

CSC0001


Responsible Party

Principal Investigator

Study Sponsor

Università degli Studi di Brescia


Study Sponsor

, , 


Verification Date

June 2016