Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00844389|
Recruitment Status : Unknown
Verified September 2009 by Universidad de Valparaiso.
Recruitment status was: Active, not recruiting
First Posted : February 16, 2009
Last Update Posted : October 1, 2009
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma||Device: Near to infrared light retinal stimulation Device: Green light stimulation||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||March 2010|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|