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

Not Applicable

• Conditions: Central Serous Chorioretinopathy
• Interventions: Procedure: Photodynamic therapy

• Registration Number: NCT01630863
• Lead Sponsor: Yeungnam University College of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-13
• Last Update Posted: 2015-02-16
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
2. Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
3. Presence of abnormal dilated choroidal vasculature in ICGA
4. Patients with symptomatic CSC of at least 3 months duration

Exclusion Criteria

1. 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
2. Patients receiving exogenous corticosteroid treatment
3. Patients with systemic diseases such as Cushing's disease or renal diseases
4. Pregnant patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40% group	Photodynamic therapy	Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.
30% group	Photodynamic therapy	Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.
50% group	Photodynamic therapy	power of PDT is applied to the patients at 50% of the full energy based on TAP study.

Primary Outcome Measures

Name	Time	Method
Changes of best corrected visual acuity	6 month	Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT

Secondary Outcome Measures

Name	Time	Method
Change of central retinal thickness, success rate, recurrence rate, and complications	6 months	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.

Trial Locations

Locations (1)

Yeungnam University College of Medicine; 🇰🇷 Daegu, Korea, Republic of