Treatment Trial for Acute Central Serous Chorioretinopathy

Acute Central Serous Chorioretinopathy Clinical Trial

Official title:

Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784665
• Other study ID #: 577MPTAC
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 2018

Study information

• Verified date: August 2018
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be treated with traditional laser photocoagulation, but it has the side effects of causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment but it's more than most families can afford to pay because of the high cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium (RPE) atrophy and RPE rip.

To date there is no international consensus on the optimal treatment of CSC Many retrospective studies suggest that micropulse laser (MPL) therapy may also be effective without obvious complications in this disease.

The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute central serous chorioretinopathy compared with the traditional laser coagulation.

Description:

The study is a prospective randomized controlled trial about 577nm micropulse laser versus traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3 months after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• 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 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 LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the
• 577-TL
All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm. 100 microns light spot size, 0.05 seconds duration, 80 ~ 200 milliwatts of power

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jin Chen-jin

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)	3 month
Secondary	Change of Best Corrected Visual Acuity (BCVA)		1months,3 months and 6 months
Secondary	Change of fundus autofluorescence	Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment	1months,3 months and 6 months
Secondary	Change in 10° retinal sensitivity		baseline,1months,3 months and 6 months