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Completed

NCT Number: NCT02784665

Treatment Trial for Acute Central Serous Chorioretinopathy

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.

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Key information

Conditions

Acute Central Serous Chorioretinopathy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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

Primary outcomes

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

    Time frame: 3 month

    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 outcomes

  1. Change of Best Corrected Visual Acuity (BCVA)

    Time frame: 1months,3 months and 6 months

  2. Change of fundus autofluorescence

    Time frame: 1months,3 months and 6 months

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

  3. Change in 10° retinal sensitivity

    Time frame: baseline,1months,3 months and 6 months

Sponsors and collaborators

Lead sponsor

Jin Chen-jin

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 27, 2016
Registry last updated
Aug 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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