Ignite Creation Date:
2024-05-06 @ 8:26 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02735213
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2016-03-16
Brief Title:
Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
Sponsor:
The Eye Hospital of Wenzhou Medical University
Organization:
The Eye Hospital of Wenzhou Medical University
Study Overview
Official Title:
A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to observe whether micropulse laser MPL is noninferiority to traditional laser therapy in central serous chorioretinopathy
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 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 acuityThis 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
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 acuityThis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None