We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 53 for:    "Central serous chorioretinopathy"

Treatment Trial for Acute Central Serous Chorioretinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02784665
Recruitment Status : Enrolling by invitation
First Posted : May 27, 2016
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Acute Central Serous Chorioretinopathy Device: 577-MPL Device: 577-TL

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy
Study Start Date : April 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 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
Active Comparator: 577-TL
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

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



Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Contacts and Locations

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): NCT02784665


Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Jin Chen-jin
Investigators
Principal Investigator: Chenjin Jin Zhongshan Ophthalmic Center, Sun Yet-sen University
More Information

Responsible Party: Jin Chen-jin, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02784665     History of Changes
Other Study ID Numbers: 577MPTAC
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jin Chen-jin, Sun Yat-sen University:
CSC
Micropulse Laser
Traditional Laser

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