NCT01327170

Brief Summary

The aim of this study was to evaluate safety and therapeutic response to micropulse diode 810nm laser treatment in patients with chronic central serous chorioretinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

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, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
Last Updated

April 1, 2011

Status Verified

March 1, 2011

Enrollment Period

1.1 years

First QC Date

March 29, 2011

Last Update Submit

March 30, 2011

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    Best corrected visual acuity measured by ETDRS chart at baseline, 1, 3, 6, 9 and 12 months

    6 months

Secondary Outcomes (2)

  • Macular subretinal fluid

    6 months

  • Leakage at fluorescein angiogram

    6 months

Study Arms (2)

Subthreshold diode micropulse laser

ACTIVE COMPARATOR

Subthreshold diode micropulse laser in patients with chronic central serous chorioretinopathy

Procedure: Subthreshold diode micropulse laser

Sham

SHAM COMPARATOR

Sham group simulating the laser treatment

Procedure: Subthreshold diode micropulse laser

Interventions

Subthreshold diode micropulse laserPROCEDURE
ShamSubthreshold diode micropulse laser

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic active central serous chorioretinopathy lasting more than 6 months
  • Leakage at fluorescein angiogram

You may not qualify if:

  • Opacities of the clear refractive media of the eye
  • Any intraocular surgery within the 6 months prior to study entry
  • Prior vitrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04023-062, Brazil

Location

Related Publications (1)

  • 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 Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Fernanda P Magalhaes, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2011

First Posted

April 1, 2011

Study Start

November 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

April 1, 2011

Record last verified: 2011-03

Locations

BR(1)