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Trial record 23 of 141 for:    MPL

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

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ClinicalTrials.gov Identifier: NCT02587767
Recruitment Status : Active, not recruiting
First Posted : October 27, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Chen-jin, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Central Serous Chorioretinopathy Device: 577-MPL Device: HD-PDT Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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Arm Intervention/treatment
Experimental: 577-MPL
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
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.

Active Comparator: HD-PDT
Half-dose photodynamic therapy (HD-PDT) is administered to the patients. At 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689nm, and a treatment duration of 83 seconds.
Device: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587767


Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Chenjin Jin Zhongshan Ophthalmic Center, Sun Yat-sen University
Principal Investigator: Lijun Zhou Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Jin Chen-jin, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02587767     History of Changes
Other Study ID Numbers: 577MPLACS(Marshall Study)
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: it is undecided to make individual participant data available when the study is going on

Additional relevant MeSH terms:
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Central Serous Chorioretinopathy
Retinal Diseases
Eye Diseases