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

Chronic Central Serous Chorioretinopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434095
• Other study ID #: 81004
• Status: Completed
• Phase: N/A
• First received: September 13, 2011
• Last updated: September 14, 2011
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: September 2011
• Source: Surugadai Nihon University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Chronic Central Serous Chorioretinopathy

Intervention

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.

Locations

Country	Name	City	State
Japan	Department of Ophthalmology, Surugadai Nihon University Hospital	Chiyoda-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Surugadai Nihon University Hospital	Teikyo University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity		one year	No
Secondary	retinal sensitivity		one year	No