The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

Study Overview
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Brief Summary
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To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.

Official Title
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The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

Conditions
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Central Serous Chorioretinopathy

Intervention / Treatment
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* Procedure: Photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT) Presence of abnormal dilated choroidal vasculature in ICGA Patients with symptomatic CSC of at least 3 months duration Exclusion Criteria: Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA Patients receiving exogenous corticosteroid treatment Patients with systemic diseases such as Cushing's disease or renal diseases Pregnant patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50% group<br>power of PDT is applied to the patients at 50% of the full energy based on TAP study. | Procedure: Photodynamic therapy<br>* Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.<br>|
| Experimental: 40% group<br>Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study. | Procedure: Photodynamic therapy<br>* Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.<br>|
| Experimental: 30% group<br>Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study. | Procedure: Photodynamic therapy<br>* Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of best corrected visual acuity | Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of central retinal thickness, success rate, recurrence rate, and complications | Change of the central retinal thickness on optical coherence tomography (OCT)are compared at baseline at 1, 3, and 6 months after PDT. Additionally, success rate, recurrence rate, and complications between three groups are evaluated during 6 months. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central serous chorioretinopathy, photodynamic therapy, safe and effective dose