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

Early Phase 1

• Conditions: Open Angle Glaucoma
• Interventions: Device: Near to infrared light retinal stimulation; Device: Green light stimulation

• Registration Number: NCT00844389
• Lead Sponsor: Universidad de Valparaiso

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.

Study Timeline

• Study First Submitted: 2009-02-13
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2009-04
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-30
• Last Update Posted: 2009-10-01
• Primary Completion: 2009-12
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIR light	Near to infrared light retinal stimulation	Group of patients stimulated with near to infrared light daily stimulation
Green light	Green light stimulation	Group of patients stimulated with green light.

Primary Outcome Measures

Name	Time	Method
Pattern electroretinogram response	Every two weeks for 4 months

Secondary Outcome Measures

Name	Time	Method
OCT ganglion cell layer average thickness, Visual Field defects	Every month for four months

Trial Locations

Locations (1)

Servicio de Oftalmología Hospital Van Buren; 🇨🇱 Valparaiso, Chile