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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy

Conditions
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Open Angle Glaucoma

Intervention / Treatment
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* Device: Near to infrared light retinal stimulation
* Device: Green light stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIR light<br>Group of patients stimulated with near to infrared light daily stimulation | Device: Near to infrared light retinal stimulation<br>* 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.<br>|
| Placebo Comparator: Green light<br>Group of patients stimulated with green light. | Device: Green light stimulation<br>* Patients will be stimulated with 530 nm LED light frequency through a LED device. Patients will be stimulated daily for two minutes for a 6 month period.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Angle Glaucoma, Biophotomodulation, Near to Infrared light stimulation, Neuroprotection