Near to Infrared (NIR) Light Neuroprotection in Glaucomat... | NCT00844389

Studies
Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy

NCT00844389

Sponsor

Universidad de Valparaiso

Status

Unknown status

Last Update Posted

Oct 1, 2009Estimated

Enrollment

40Estimated

Phase

Early Phase 1

Conditions

Open Angle Glaucoma

Interventions

Near to infrared light retinal stimulation
Green light stimulation

Countries

Chile

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

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Dec 2009Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Feb 13, 2009

First Submission Date that Met QC Criteria

Feb 13, 2009

First Posted Date

Feb 16, 2009Estimated

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

Sep 30, 2009

Last Update Posted Date

Oct 1, 2009Estimated

Name	Class
Comisión Nacional de Investigación Científica y Tecnológica	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.

Detailed Description

Ganglion cell dysfunction in glaucomatous optic neuropathy has been ascribed to ganglion cell electrophysiological inactivation and to apoptotic cell death. Near-to-infrared light stimulation has been used to induce mitochondrial activation and to prevent apoptotic death through mitochondrial cytochrome oxidase c stimulation. Near-to-infrared light stimulation might be useful to induce ganglion cell activation and inhibit apoptotic cell death.

We propose that near-to-infrared light stimulation can be used as an adjuvant treatment combined with ocular hypotensive treatment in glaucomatous patients.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIR light	Active Comparator	Group of patients stimulated with near to infrared light daily stimulation	Device: Near to infrared light retinal stimulation
Green light	Placebo Comparator	Group of patients stimulated with green light.	Device: Green light stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Near to infrared light retinal stimulation	Device	Patients will be stimulated with 660 nm light frequency through a LED device. Patients will be stimulated daily for two minutes for a 6 month period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pattern electroretinogram response		Every two weeks for 4 months

Secondary Outcomes

Measure	Description	Time Frame
OCT ganglion cell layer average thickness, Visual Field defects		Every month for four months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnose of Ocular Hypertension (cup to disk ratio 0,6 or less, normal Humphrey 24-2 visual field with aplanatic IOP over 21 mmHg) or Mild Glaucoma (cup to disk ratio 0,6 to 0,8, characteristic Humphrey 24-2 visual field defect PSD between 3 and 6 dB).
Visual acuity 20/40 or better

Exclusion Criteria:

Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
Refractive error of 3 diopters or more

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tatiana E Cevo, M.D	Universidad de Valparaiso	Principal Investigator
Adrian Palacios, PhD	Universidad de Valparaiso	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servicio de Oftalmología Hospital Van Buren		Valparaíso	Valparaiso		Chile

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided