Back to resultsMicroperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Primary Purpose
Chronic Central Serous Chorioretinopathy
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
half-dose photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Central Serous Chorioretinopathy focused on measuring microperimetry, fixation point, retinal sensitivity, photodynamic therapy, chronic central serous chorioretinopathy
Eligibility Criteria
Inclusion Criteria:
- the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images
- a serous retinal detachment of at least 6 months duration.
Exclusion Criteria:
- evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography
Sites / Locations
- Department of Ophthalmology, Surugadai Nihon University Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
half-dose PDT(photodynamic therapy)
Arm Description
The study include single arm; treated group, and no control group was included.
Outcomes
Primary Outcome Measures
best corrected visual acuity
Secondary Outcome Measures
retinal sensitivity
Full Information
NCT ID
NCT01434095
First Posted
September 13, 2011
Last Updated
September 14, 2011
Sponsor
Surugadai Nihon University Hospital
Collaborators
Teikyo University
1. Study Identification
Unique Protocol Identification Number
NCT01434095
Brief Title
Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Surugadai Nihon University Hospital
Collaborators
Teikyo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A half-dose photodynamic therapy, a relative new treatment, has been widely performed to treat central serous chorioretinopathy.
The researchers aimed to investigate whether the therapy improved the patient's visual acuity as well as the retinal sensitivity. The researchers also investigate which clinical factors, if any, were associated with the results; visual acuity or retinal sensitivity after the treatment.
Detailed Description
The best-corrected visual acuity (BCVA), macular sensitivity, and fixation stability were evaluated at the baseline and at 1, 3, 6, and 12 months after the half-dose photodynamic therapy. The macular sensitivity and fixation stability were determined by MP-1 microperimetry (Nidek, Vigonza, Italy). The researchers analysed whether the BCVA and retinal sensitivity significantly improved or not. And if yes, the researchers were interested at which period after treatment the significant improvement was found. Also, the researchers investigated which improved first, BCVA or retinal sensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Central Serous Chorioretinopathy
Keywords
microperimetry, fixation point, retinal sensitivity, photodynamic therapy, chronic central serous chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
half-dose PDT(photodynamic therapy)
Arm Type
Active Comparator
Arm Description
The study include single arm; treated group, and no control group was included.
Intervention Type
Procedure
Intervention Name(s)
half-dose photodynamic therapy
Intervention Description
photodynamic therapy (PDT) was performed using 3 mg/m2 body surface area of verteporfin (Visudyne, Novartis AG, Bülach, Switzerland) which is one-half the conventional dose of verteporfin. The verteporfin was infused over a 10 minute period followed by the delivery of 50 J/cm2 from a 689-nm laser system (Carl Zeiss, Dublin, CA) over an 83-second exposure time.
Primary Outcome Measure Information:
Title
best corrected visual acuity
Time Frame
one year
Secondary Outcome Measure Information:
Title
retinal sensitivity
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the presence of subretinal fluid involving the fovea in the Optical coherence tomographic (OCT) images
a serous retinal detachment of at least 6 months duration.
Exclusion Criteria:
evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoko Fujita, MD, PhD
Organizational Affiliation
Department of Ophthalmology, Surugadai Nihon University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Surugadai Nihon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22818904
Citation
Fujita K, Shinoda K, Imamura Y, Matsumoto CS, Mizutani Y, Mizota A, Yuzawa M. Correlation of integrity of cone outer segment tips line with retinal sensitivity after half-dose photodynamic therapy for chronic central serous chorioretinopathy. Am J Ophthalmol. 2012 Sep;154(3):579-85. doi: 10.1016/j.ajo.2012.03.043. Epub 2012 Jul 20.
Results Reference
derived
Learn more about this trial
Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
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