Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedSeptember 15, 2011
September 1, 2011
1.7 years
September 13, 2011
September 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
best corrected visual acuity
one year
Secondary Outcomes (1)
retinal sensitivity
one year
Study Arms (1)
half-dose PDT(photodynamic therapy)
ACTIVE COMPARATORThe study include single arm; treated group, and no control group was included.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- evidence of a choroidal neovascularization (CNV), polypoidal choroidal vasculopathy, or other maculopathy documented by fluorescein angiography or Indocyanine green angiography
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Surugadai Nihon University Hospitallead
- Teikyo Universitycollaborator
Study Sites (1)
Department of Ophthalmology, Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309, Japan
Related Publications (1)
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.
PMID: 22818904DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoko Fujita, MD, PhD
Department of Ophthalmology, Surugadai Nihon University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Kyoko Fujita, MD, PhD
Study Record Dates
First Submitted
September 13, 2011
First Posted
September 14, 2011
Study Start
October 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
September 15, 2011
Record last verified: 2011-09