Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy
Recruitment status was: Active, not recruiting
|Open Angle Glaucoma||Device: Near to infrared light retinal stimulation Device: Green light stimulation||Early Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy|
- Pattern electroretinogram response [ Time Frame: Every two weeks for 4 months ]
- OCT ganglion cell layer average thickness, Visual Field defects [ Time Frame: Every month for four months ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||March 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Active Comparator: NIR light
Group of patients stimulated with near to infrared light daily stimulation
Device: Near to infrared light retinal stimulation
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.
Placebo Comparator: Green light
Group of patients stimulated with green light.
Device: Green light stimulation
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844389
|Servicio de Oftalmología Hospital Van Buren|
|Principal Investigator:||Tatiana E Cevo, M.D||Universidad de Valparaiso|
|Study Director:||Adrian Palacios, PhD||Universidad de Valparaiso|