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

Acute Central Serous Chorioretinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587767
• Other study ID #: 577MPLACS(Marshall Study)
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Central Serous Chorioretinopathy
• Central Serous Chorioretinopathy

Intervention

Device:
• 577-MPL
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-PDT
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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 month
Secondary	Change of Best Corrected Visual Acuity(BCVA)		1 month, 3 month, 6 month
Secondary	Change of fundus autofluorescence	Fundus autofluorescence will be evaluated for different patterns(normal, increased, and decreased)before and after treatment	1 month, 3 month, 6 month
Secondary	Change in 10°retinal sensitivity	Retinal sensitivity will be measured by microperimetry	1 month, 3 month, 6 month
Secondary	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	6 month