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Completed

NCT Number: NCT02587767

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

The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.

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Key information

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

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.

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 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

Device

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 outcomes

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

    Time frame: 1 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: 1 month, 3 month, 6 month

  2. Change of fundus autofluorescence

    Time frame: 1 month, 3 month, 6 month

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

  3. Change in 10°retinal sensitivity

    Time frame: 1 month, 3 month, 6 month

    Retinal sensitivity will be measured by microperimetry

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

    Time frame: 6 month

    The outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Prospective Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2015
Registry last updated
Apr 5, 2022

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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