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

Sponsor

Surugadai Nihon University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01434095

Collaborator

Teikyo University (Other)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Central Serous Chorioretinopathy	Procedure: half-dose photodynamic therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

best corrected visual acuity [one year]

Secondary Outcome Measures

retinal sensitivity [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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