Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

Central Serous Choroidopathy Clinical Trial

Official title:

A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02735213
• Other study ID #: Y-2016005
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: July 2019
• Source: The Eye Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Central Serous Choroidopathy

Intervention

Device:
• 577-MPL
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.
• TLT
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.

Locations

Country	Name	City	State
China	The eye of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Eye Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. — View Citation

Iacono P, Battaglia Parodi M, Falcomatà 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. Review. — View 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. — View 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;(12):CD011841. doi: 10.1002/14651858.CD011841.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Best Corrected Visual Acuity (BCVA)	ETDRS BCVA	12 week
Secondary	the number of patients without any subretinal fluid (SRF)	SRF	3 week, 7 week, 12 week
Secondary	Change of the central retinal thickness (CRT)	CRT	3 week, 7 week, 12 week
Secondary	laser scar in area lasered on	colour image and OCT infared image	12 week
Secondary	the number of patients need retreatment	PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um	12 week