Treatment Trial for Acute Central Serous Chorioretinopathy

NCT02784665 | Completed DMC

• 1 other identifier: 577MPTAC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Central Serous Chorioretinopathy

Keywords

CSC; Micropulse Laser; Traditional Laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Best Corrected Visual Acuity (BCVA)

  1months,3 months and 6 months

• Change of fundus autofluorescence

  1months,3 months and 6 months

• Change in 10° retinal sensitivity

  baseline,1months,3 months and 6 months

Study Arms (2)

577-MPL

EXPERIMENTAL

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.

Device: 577-MPL

577-TL

ACTIVE COMPARATOR

577nm Traditional laser(577-TL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Traditional laser spots will be applied, covering the leakage area.

Device: 577-TL

Interventions

577-MPL DEVICE

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-MPL

577-TL DEVICE

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

577-TL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jin Chen-jin: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Chenjin Jin

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 27, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

CN (1)