None listed
Conditions
Brief summary
Purpose This randomized controlled pilot clinical trial aims to compare the efficacy and safety of half-dose photodynamic therapy(PDT) and subthreshold micropulse yellow (577-nm) laser in central serous chorioretinopathy (CSCR). Methods This will be a prospective, double-masked, randomized controlled study. Patients with CSCR attending at Hong Kong Eye Hospital between January 2016 and December 2016 will be recruited in the study. If both eyes meet the inclusion criteria, only the right eye will be included in bilateral cases. Patients will be randomized into the half-dose PDT group or the subthreshold micropulse yellow (577-nm) laser group at a ratio of 1:1. All patients and investigators will be masked to the treatment allocation group. Assessors performing the follow-up assessments also will be masked to the patient allocation group. Half-dose Photodynamic therapy The PDT will be performed using half-dose verteporfin (Visudyne; Novartis AG). For this, 3 mg/m2 of verteporfin will be infused over 10 minutes, and 15 minutes after beginning the infusion, the laser treatment will be begun. The total light energy delivered to the area of hyperpermeability is 50 J/cm2 over 83 seconds. Subthreshold micropulse yellow laser The focal leaking points and areas of hyperpermeability will be treated with the subthreshold micropulse laser therapy with 577nm yellow laser (IRIDEX IQ 577 laser, USA). In the micropulse laser group, 30 ml normal saline will be infused instead of verteporfin, before application of micropulse laser. Baseline and follow-up examinations Patients will be assessed at baseline and followed up at 1, 3, 6, 9 and 12 months after the treatment. At the baseline and all post-treatment visits, best-corrected visual acuity (BCVA), will be measured. The optical coherence topography (OCT) (Topcon DRI OCT, Triton OCT, Japan; Spectralis OCT, Heidelberg Engineering Inc., Heidelberg, Germany) and microperimtery will be performed before the treatment as well as at each clinical visit. Patients with persistent subretinal fluid will have further fluorescein angiography (FA) and indocyanine green angiography (ICGA) as decided by the assessors. Retreatment will be considered if the patients meet two of the three following criteria: decreased visual acuity of at least one line from baseline, presence of subretinal fluid on OCT, and significant leakage on angiography. Patients in the PDT group will be considered for retreatment every 6 months whereas patients in the micropulse laser group will be considered for retreatment every 3 months. Patients who have persistent SRF after 3 treatments of micropulse laser will receive half-dose photodynamic therapy as rescue therapy, 3 months after the third micropulse laser treatment. The primary outcome of the study is the proportion of eyes with complete absorption of subretinal fluid (SRF) at 12 months. Secondary outcome measures included serial changes in logMAR BCVA, central foveal th
Interventions
Half-dose Photodynamic therapy
The Photodynamic therapy (PDT)(intravenous infusion) will be performed using half-dose verteporfin (Visudyne; Novartis). For this, 3 mg/m2 of verteporfin will be infused over 10 minutes, and 15 minutes after beginning the infusion, the laser treatment will be begun. The total light energy delivered to the area of hyperpermeability is 50 J/cm2 over 83 seconds. The area of irradiation will be set to cover the hyperfluorescent area measured in the images recorded duri
Half-dose Photodynamic therapy The Photodynamic therapy (PDT)(intravenous infusion) will be performed using half-dose verteporfin (Visudyne; Novartis). For this, 3 mg/m2 of verteporfin will be infused over 10 minutes, and 15 minutes after beginning the infusion, the laser treatment will be begun. The total light energy delivered to the area of hyperpermeability is 50 J/cm2 over 83 seconds. The area of irradiation will be set to cover the hyperfluorescent area measured in the images recorded during the middle to late phases of indocyanine green angiography (ICGA). If both eyes meet the inclusion criteria, only the right eye will be included in bilateral cases. In photodynamic therapy, a light-sensitive medicine called verteporin (Visudyne) is injected into the bloodstream. Laser light is then shone into the eye, which activates the medicine and the abnormal choroidal blood vessels is treated. In micropulse laser, a continuous-wave laser beam is chopped into a train of tiny, repetitive, low energy pulses, to treat the areas of diseased retinal pigment epithelium (RPE), inducing resorption of the subretinal fluid. Patients in the PDT group will be considered for retreatment every 6 months whereas patients in the micropulse laser group will be considered for retreatment every 3 months. Patients who have persistent subretinal fluid after 3 treatments of micropulse laser will receive half-dose photodynamic therapy as rescue therapy, 3 months after the third micropulse laser treatment. In the PDT group, patient who have persistent subretinal fluid 6 months after the initital treatment will receive second half-dose photodynamic therapy.
Sponsors
Brelen Marten Erik
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) CSCR is defined by idiopathic, single, or multiple serous detachments of the neurosensory retina in the macular area associated with RPE changes or RPE leaks on fluorescein angiography (FA) and visual symptoms for less than 3 months(acute CSCR) or more than 3 months (chronic CSCR) (2) Patient with 18 years or older (3) Absence of spontaneous resolution or improvement induced by empirical treatment such as acetazolamide or ketoconazole (4) Presence of written informed consent
Exclusion criteria
(1) Any previous treatment, including PDT and focal thermal laser photocoagulation, for CSCR (2) Iatrogenic CSC caused by corticosteroids (3) FA or ICGA findings of CNV, polyploidal choroidal vasculopathy (PCV) (4) Other maculopathy on clinical examination, FA, indocyanine green angiography (ICGA) (5) Media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images
Outcome results
None listed