Central Serous Chorioretinopathy, Therapy, Photodynamic
Conditions
Brief summary
This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.
Interventions
PROCEDURE50% dose of photodynamic therapy
Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 50% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.
PROCEDURE70% dose of photodynamic therapy
Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 70% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years old, regardless of gender; * Meet the diagnostic criteria of central serous chorioretinopathy; * The course of CSC (subject to the symptoms of this disease) is more than 3 months; * Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.
Exclusion criteria
* macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases; * a previous history of PDT treatment; * systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The complete absorption rate of subretinal fluid | 3 months after the primary PDT | The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central foveal thickness change after the PDT | 12 months after the PDT | The hight of central foveal thickness was measured on optical coherence tomography at each visit |
| Subfoveal choroidal thickness change after the PDT | 12 months after the PDT | The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit |
| Best corrected visual acuity change after the PDT | 12 months after the PDT | The BCVA was tested at each visit |
Countries
China
Contacts
Primary ContactYuou Yao, Dr
Backup ContactMingwei Zhao, Dr
Outcome results
None listed