Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Di... | NCT00552435

Studies
Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema

NCT00552435

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

May 7, 2008Estimated

Enrollment

50Estimated

Phase

Phase 2

Conditions

Diabetic Macular Edema

Interventions

Laser photocoagulation

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Nov 2008Estimated

Completion Date

Nov 2008Estimated

First Submitted Date

Oct 31, 2007

First Submission Date that Met QC Criteria

Oct 31, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2008

Last Update Posted Date

May 7, 2008Estimated

Description Module

Brief Summary

Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.The single density is based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation technique and the double density increases the number of spots.

Methods: Patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Micropulse 810nm diode laser	Device: Laser photocoagulation
2	Active Comparator	Argon laser photocoagulation	Device: Laser photocoagulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser photocoagulation	Device	Laser therapy is applied using a slit lamp and specific laser contact lens.	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Macular thickness measured by optical coherence tomography (OCT)		12 months

Secondary Outcomes

Measure	Description	Time Frame
Safety profile		12 months
Selectivity of laser therapy (autofluorescence and mfERG)		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetes mellitus (type 1 or 2)
Diabetic macular edema in study eye associated to diabetic retinopathy
Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

Uncontrolled systemic disease
Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
HbA1c levels greater than 10%
Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
Presence of epiretinal membrane
Presence of vitreomacular traction in the study eye.
Neovascularization of disc or elsewhere in the study eye.
History or presence of choroidal neovascularization in the study eye.
Presence of rubeosis irides in the study eye.
Eye opacity that interfere with clinical documentation and photography.
Intra-ocular surgery 90 days before initial visit.
Scheduled surgery for study eye.
Patients with known allergies to fluorescein.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Lavinsky	Contact	55-11-7658-8669		lavinsky@via-rs.net
Jose A Cardillo	Contact	55-16-8115-1000		hospitaldeolhos@uol.com.br

Overall Officials

Name	Affiliation	Role
Jose A Cardillo	Federal University of Sao Paulo- Department of Ophthalmology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vision Institute, Federal University of Sao Paulo	Recruiting	São Paulo	São Paulo		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21345996	Derived	Lavinsky D, Cardillo JA, Melo LA Jr, Dare A, Farah ME, Belfort R Jr. Randomized clinical trial evaluating mETDRS versus normal or high-density micropulse photocoagulation for diabetic macular edema. Invest Ophthalmol Vis Sci. 2011 Jun 17;52(7):4314-23. doi: 10.1167/iovs.10-6828.