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

This study has been completed.
Sponsor:
Collaborator:
Teikyo University
Information provided by (Responsible Party):
Kyoko Fujita, Surugadai Nihon University Hospital
ClinicalTrials.gov Identifier:
NCT01434095
First received: September 13, 2011
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

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 Intervention
Chronic Central Serous Chorioretinopathy
Procedure: half-dose photodynamic therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Surugadai Nihon University Hospital:

Primary Outcome Measures:
  • best corrected visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • retinal sensitivity [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434095

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

No publications provided by Surugadai Nihon University Hospital

Additional 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
Study First Received: September 13, 2011
Last Updated: September 14, 2011
Health Authority: Japan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014