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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
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Device: Near to infrared light retinal stimulation Device: Green light stimulation Early Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : April 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Pattern electroretinogram response [ Time Frame: Every two weeks for 4 months ]

Secondary Outcome Measures :
  1. OCT ganglion cell layer average thickness, Visual Field defects [ Time Frame: Every month for four months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Chile
Servicio de Oftalmología Hospital Van Buren
Valparaiso, Chile
Sponsors and Collaborators
Universidad de Valparaiso
Comisión Nacional de Investigación Científica y Tecnológica
Investigators
Principal Investigator: Tatiana E Cevo, M.D Universidad de Valparaiso
Study Director: Adrian Palacios, PhD Universidad de Valparaiso

Responsible Party: Tatiana Cevo, Universidad de Valparaíso
ClinicalTrials.gov Identifier: NCT00844389     History of Changes
Other Study ID Numbers: ACT45-GLAUC
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009

Keywords provided by Universidad de Valparaiso:
Open Angle Glaucoma
Biophotomodulation
Near to Infrared light stimulation
Neuroprotection

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Optic Nerve Diseases
Ocular Hypertension
Eye Diseases
Cranial Nerve Diseases
Nervous System Diseases