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

NCT02735213 | Completed Phase 2 DMC

• 1 other identifier: Y-2016005
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Central Serous Choroidopathy

Keywords

Central Serous Choroidopathy; Micropulse Laser Treatment; Traditional laser Treatment; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Change of Best Corrected Visual Acuity (BCVA)

  ETDRS BCVA

  12 week

Secondary Outcomes (4)

• the number of patients without any subretinal fluid (SRF)

  3 week, 7 week, 12 week

• Change of the central retinal thickness (CRT)

  3 week, 7 week, 12 week

• laser scar in area lasered on

  12 week

• the number of patients need retreatment

  12 week

Study Arms (2)

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.

Device: 577-MPL

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.

Device: TLT

Interventions

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.

577-MPL

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.

TLT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Eye Hospital of Wenzhou Medical University: lead

Study Sites (1)

The eye of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (5)

• 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.

  PMID: 26691378 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.

  PMID: 26619293 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.

  PMID: 26026923 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.

  PMID: 11884873 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.

  PMID: 3061449 BACKGROUND

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 12, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

CN (1)