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The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.
Central serous chorioretinopathy (CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity. Some studies have shown that traditional laser treatment (TLT) is effective on CSC, although accompanied with side-effects, such as scar. 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 TLT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus traditional laser treatment in central serous chorioretinopathy. It is a noninferiority study. The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity.This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment. The primary outcome measures is the change of BCVA in 12 week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 577-MPL | Experimental | 577nm subthreshold micropulse laser(577-MPL) will be performed on the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein. Multiple laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um. |
|
| TLT | Active Comparator | Traditional laser 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. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 577-MPL | Device | 9 spots multispot micropulse mode(without spacing between the spots),160 um spot size, 0.2 second duration, 5% duty cycle(ON time 0.1ms + OFF time 1.9ms), and 250~400 milliWatts of power(50% threshold power),150~200 spots, the laser area is the corresponding leakage on mid-phase FA and around leakage. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Best Corrected Visual Acuity (BCVA) | ETDRS BCVA | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients without any subretinal fluid (SRF) | SRF | 3 week, 7 week, 12 week |
| Change of the central retinal thickness (CRT) | CRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The eye of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26691378 | Background | Salehi M, Wenick AS, Law HA, Evans JR, Gehlbach P. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2015 Dec 22;(12):CD011841. doi: 10.1002/14651858.CD011841.pub2. | |
| 26619293 | Background | Iacono P, Battaglia Parodi M, Falcomata B, Bandello F. Central Serous Chorioretinopathy Treatments: A Mini Review. Ophthalmic Res. 2015;55(2):76-83. doi: 10.1159/000441502. Epub 2015 Dec 1. |
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| ID | Term |
|---|---|
| D056833 | Central Serous Chorioretinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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|
| TLT | Device | contimuous wave,100um spot size, 0.05 seconds duration, 55~60 milliwatts of power, 18~27 spots,the laser area is the corresponding leakage on mid-phase FA. |
|
| 3 week, 7 week, 12 week |
| laser scar in area lasered on | colour image and OCT infared image | 12 week |
| the number of patients need retreatment | PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um | 12 week |
| 26026923 | Background | Daruich A, Matet A, Dirani A, Bousquet E, Zhao M, Farman N, Jaisser F, Behar-Cohen F. Central serous chorioretinopathy: Recent findings and new physiopathology hypothesis. Prog Retin Eye Res. 2015 Sep;48:82-118. doi: 10.1016/j.preteyeres.2015.05.003. Epub 2015 May 27. |
| 11884873 | Background | Loo RH, Scott IU, Flynn HW Jr, Gass JD, Murray TG, Lewis ML, Rosenfeld PJ, Smiddy WE. Factors associated with reduced visual acuity during long-term follow-up of patients with idiopathic central serous chorioretinopathy. Retina. 2002 Feb;22(1):19-24. doi: 10.1097/00006982-200202000-00004. |
| 3061449 | Background | Ficker L, Vafidis G, While A, Leaver P. Long-term follow-up of a prospective trial of argon laser photocoagulation in the treatment of central serous retinopathy. Br J Ophthalmol. 1988 Nov;72(11):829-34. doi: 10.1136/bjo.72.11.829. |