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
|Condition or disease||Intervention/treatment||Phase|
|Acute Central Serous Chorioretinopathy||Device: 577-MPL Device: HD-PDT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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.
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.
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.
- 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
- Change of Best Corrected Visual Acuity(BCVA) [ Time Frame: 1 month, 3 month, 6 month ]
- 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
- Change in 10°retinal sensitivity [ Time Frame: 1 month, 3 month, 6 month ]Retinal sensitivity will be measured by microperimetry
- 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
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
|Zhongshan Ophthalmic Center, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Study Director:||Chenjin Jin||Zhongshan Ophthalmic Center, Sun Yat-sen University|
|Principal Investigator:||Lijun Zhou||Zhongshan Ophthalmic Center, Sun Yat-sen University|