577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

Sun Yat-sen University68 enrolled

Overview

The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.

Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity.Some studies have shown that Half-dose photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant price.Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between PDT and MPL. The study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null hypothesis of the study is that there is difference between MPL and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Central Serous Chorioretinopathy

Interventions

577-MPLDEVICE

All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle.

HD-PDTDEVICE

5 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will been performed in HD-PDT arm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. onset for the first time, as an episode duration of less than 6 months 2. patient was between 18 and 55 years of age 3. the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT) 4. active fluorescein leakage during fluorescein angiography (FA) 5. best corrected visual acuity (BCVA) more than 0.1, and less than 1.0 Exclusion Criteria: 1. previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery 2. other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV) 3. retinal atrophy 4. pregnancy 5. inability to obtain photographs or to perform FA 6. use of steroid systemically or topically in the last 6 months

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

the proportion of eyes with complete absorption of subretinal fluid(SRF)

The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images

Time frame: 1 month

Secondary Outcomes

Change of Best Corrected Visual Acuity(BCVA)

Time frame: 1 month, 3 month, 6 month

Change of fundus autofluorescence

Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment

Time frame: 1 month, 3 month, 6 month

Change in 10°retinal sensitivity

Retinal sensitivity will be measured by microperimetry

Time frame: 1 month, 3 month, 6 month

the proportion of eyes with complete absorption of subretinal fluid(SRF)

The outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images

Time frame: 6 month

Data from ClinicalTrials.gov

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