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

Universidad de Valparaiso

Status and phase: Unknown; Early Phase 1

Conditions: Open Angle Glaucoma

Treatments: Device: Green light stimulation; Device: Near to infrared light retinal stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00844389

ACT45-GLAUC

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

NIR light

Active Comparator group

Description:

Group of patients stimulated with near to infrared light daily stimulation

Treatment:

Device: Near to infrared light retinal stimulation

Green light

Placebo Comparator group

Description:

Group of patients stimulated with green light.

Treatment:

Device: Green light stimulation