577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
Primary Purpose
Acute Central Serous Chorioretinopathy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
577-MPL
HD-PDT
Sponsored by
About this trial
This is an interventional treatment trial for Acute Central Serous Chorioretinopathy
Eligibility Criteria
Inclusion Criteria:
- onset for the first time, as an episode duration of less than 6 months
- patient was between 18 and 55 years of age
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- active fluorescein leakage during fluorescein angiography (FA)
- best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
Exclusion Criteria:
- previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- retinal atrophy
- pregnancy
- inability to obtain photographs or to perform FA
- use of steroid systemically or topically in the last 6 months
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
577-MPL
HD-PDT
Arm Description
577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area.
Half-dose photodynamic therapy (HD-PDT) is administered to the patients. At 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689nm, and a treatment duration of 83 seconds.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change of Best Corrected Visual Acuity(BCVA)
Change of fundus autofluorescence
Fundus autofluorescence will be evaluated for different patterns(normal, increased, and decreased)before and after treatment
Change in 10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02587767
Brief Title
577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
Official Title
Prospective Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Central Serous Chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
577-MPL
Arm Type
Experimental
Arm Description
577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area.
Arm Title
HD-PDT
Arm Type
Active Comparator
Arm Description
Half-dose photodynamic therapy (HD-PDT) is administered to the patients. At 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689nm, and a treatment duration of 83 seconds.
Intervention Type
Device
Intervention Name(s)
577-MPL
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HD-PDT
Intervention Description
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.
Primary Outcome Measure Information:
Title
the proportion of eyes with complete absorption of subretinal fluid(SRF)
Description
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 Outcome Measure Information:
Title
Change of Best Corrected Visual Acuity(BCVA)
Time Frame
1 month, 3 month, 6 month
Title
Change of fundus autofluorescence
Description
Fundus autofluorescence will be evaluated for different patterns(normal, increased, and decreased)before and after treatment
Time Frame
1 month, 3 month, 6 month
Title
Change in 10°retinal sensitivity
Description
Retinal sensitivity will be measured by microperimetry
Time Frame
1 month, 3 month, 6 month
Title
the proportion of eyes with complete absorption of subretinal fluid(SRF)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
onset for the first time, as an episode duration of less than 6 months
patient was between 18 and 55 years of age
the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
active fluorescein leakage during fluorescein angiography (FA)
best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
Exclusion Criteria:
previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
retinal atrophy
pregnancy
inability to obtain photographs or to perform FA
use of steroid systemically or topically in the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chenjin Jin
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lijun Zhou
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
it is undecided to make individual participant data available when the study is going on
Learn more about this trial
577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
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