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

Primary Purpose

Central Serous Chorioretinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
Yeungnam University College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring Central serous chorioretinopathy, photodynamic therapy, safe and effective dose

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yeungnam University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

50% group

40% group

30% group

Arm Description

power of PDT is applied to the patients at 50% of the full energy based on TAP study.

Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.

Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 26, 2012
Last Updated
February 13, 2015
Sponsor
Yeungnam University College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01630863
Brief Title
The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Official Title
The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeungnam University College of Medicine

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
Keywords
Central serous chorioretinopathy, photodynamic therapy, safe and effective dose

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
50% group
Arm Type
Experimental
Arm Description
power of PDT is applied to the patients at 50% of the full energy based on TAP study.
Arm Title
40% group
Arm Type
Experimental
Arm Description
Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study.
Arm Title
30% group
Arm Type
Experimental
Arm Description
Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes of best corrected visual acuity
Description
Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Change of central retinal thickness, success rate, recurrence rate, and complications
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Sagong
Phone
82-53-620-4191
Email
msagong@ynu.ac.kr
Facility Information:
Facility Name
Yeungnam University College of Medicine
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Sagong
Phone
82-53-620-4191
Email
msagong@ynu.ac.kr
First Name & Middle Initial & Last Name & Degree
Min Sagong

12. IPD Sharing Statement

Citations:
PubMed Identifier
32727733
Citation
Park DG, Jeong S, Noh D, Sagong M. Optimal fluence rate of photodynamic therapy for chronic central serous chorioretinopathy. Br J Ophthalmol. 2021 Jun;105(6):844-849. doi: 10.1136/bjophthalmol-2020-316837. Epub 2020 Jul 29.
Results Reference
derived

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

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