Clinical trial NCT02735213: Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
Official title: A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Central Serous Choroidopathy
Keywords: Central Serous Choroidopathy
Micropulse Laser Treatment
Traditional laser Treatment
optical coherence tomography
Lead sponsor: The Eye Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with CSC；
2. age\>=18 years old;
3. Duration is less than 6 months；
4. the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT), and CRT\>=250um;
5. active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography (FA).

Exclusion Criteria:

1. Patients with no case of CSC；
2. Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration；
3. Patients with prior retinal treatment less than 3 months；
4. Inability to obtain photographs or to perform FA

Primary outcomes:
measure: Change of Best Corrected Visual Acuity (BCVA)
timeFrame: 12 week
Secondary outcomes:
measure: the number of patients without any subretinal fluid (SRF)
timeFrame: 3 week, 7 week, 12 week
measure: Change of the central retinal thickness (CRT)
timeFrame: 3 week, 7 week, 12 week
measure: laser scar in area lasered on
timeFrame: 12 week
measure: the number of patients need retreatment
timeFrame: 12 week
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The eye of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: 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;2015(12):CD011841. doi: 10.1002/14651858.CD011841.pub2.
citation: 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.
citation: 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.
citation: 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.
citation: 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.