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Microperimetric Evaluation After Half-dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT01434095
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 15, 2011
Teikyo University
Information provided by (Responsible Party):
Kyoko Fujita, Surugadai Nihon University Hospital

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.

Condition or disease Intervention/treatment
Chronic Central Serous Chorioretinopathy Procedure: half-dose photodynamic therapy

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: half-dose PDT(photodynamic therapy)
The study include single arm; treated group, and no control group was included.
Procedure: half-dose photodynamic therapy
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 Measures :
  1. best corrected visual acuity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. retinal sensitivity [ Time Frame: one year ]

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434095

Department of Ophthalmology, Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, Japan, 101-8309
Sponsors and Collaborators
Surugadai Nihon University Hospital
Teikyo University
Principal Investigator: Kyoko Fujita, MD, PhD Department of Ophthalmology, Surugadai Nihon University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyoko Fujita, Dr. Kyoko Fujita, MD, PhD, Surugadai Nihon University Hospital
ClinicalTrials.gov Identifier: NCT01434095     History of Changes
Other Study ID Numbers: 81004
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 15, 2011
Last Verified: September 2011

Keywords provided by Kyoko Fujita, Surugadai Nihon University Hospital:
fixation point
retinal sensitivity
photodynamic therapy
chronic central serous chorioretinopathy

Additional relevant MeSH terms:
Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases