NCT01982383

Brief Summary

The investigators hypothesis is that using the micropulse laser in patient with Central Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in significantly minimizing visual recovery time from this disease as well as potentially preventing recurrences.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 27, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

November 6, 2013

Results QC Date

March 1, 2018

Last Update Submit

March 1, 2018

Conditions

Central Serous Chorioretinopathy

Keywords

CSCEdemaRetinopathy

Outcome Measures

Primary Outcomes (1)

  • Resolution of Fluid Build-up

    Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity.

    within 1 week to 3 months after the laser procedure is completed

Study Arms (2)

Micropulse Laser Treatment

EXPERIMENTAL

Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine

Device: Micropulse Laser Treatment

No Treatment

PLACEBO COMPARATOR

Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending

Other: No treatment

Interventions

Micropulse Laser TreatmentDEVICE
Also known as: Micropulse 577nm, Laser
Micropulse Laser Treatment
No treatmentOTHER
No Treatment

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with new diagnosis of CSC and no other comorbidities or prior retinal treatment
  • Patients ranging from 30 to 60 years of age

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (4)

  • Ricci F, Missiroli F, Cerulli L. Indocyanine green dye-enhanced micropulsed diode laser: a novel approach to subthreshold RPE treatment in a case of central serous chorioretinopathy. Eur J Ophthalmol. 2004 Jan-Feb;14(1):74-82. doi: 10.1177/112067210401400115.

    PMID: 15005592BACKGROUND

  • Lanzetta P, Furlan F, Morgante L, Veritti D, Bandello F. Nonvisible subthreshold micropulse diode laser (810 nm) treatment of central serous chorioretinopathy. A pilot study. Eur J Ophthalmol. 2008 Nov-Dec;18(6):934-40. doi: 10.1177/112067210801800613.

    PMID: 18988165BACKGROUND

  • Chen SN, Hwang JF, Tseng LF, Lin CJ. Subthreshold diode micropulse photocoagulation for the treatment of chronic central serous chorioretinopathy with juxtafoveal leakage. Ophthalmology. 2008 Dec;115(12):2229-34. doi: 10.1016/j.ophtha.2008.08.026.

    PMID: 19041477BACKGROUND

  • Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.

    PMID: 40522203DERIVED

MeSH Terms

Conditions

Central Serous ChorioretinopathyEdemaRetinal Diseases

Interventions

Lasers

Condition Hierarchy (Ancestors)

Eye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Results Point of Contact

Title
Nicole Swanson
Organization
Medical Faculty Associates
nswanson@mfa.gwu.edu
202-741-2437

Study Officials

  • Jeevan Mathura, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 27, 2018

Results First Posted

March 27, 2018

Record last verified: 2018-03

Locations

US(1)