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

NCT ID: NCT01434095

Last Updated: 2011-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-07-31

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.

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.

Conditions

Chronic Central Serous Chorioretinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

half-dose PDT(photodynamic therapy)

The study include single arm; treated group, and no control group was included.

Group Type: ACTIVE_COMPARATOR

half-dose photodynamic therapy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teikyo University

OTHER

Sponsor Role: collaborator

Surugadai Nihon University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyoko Fujita

Dr. Kyoko Fujita, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyoko Fujita, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Surugadai Nihon University Hospital

Locations

Department of Ophthalmology, Surugadai Nihon University Hospital

Chiyoda-ku, Tokyo, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 22818904 (View on PubMed)

Other Identifiers

81004

Identifier Type: -

Identifier Source: org_study_id