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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Universidad de Valparaiso.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Comisión Nacional de Investigación Científica y Tecnológica
Information provided by:
Universidad de Valparaiso
ClinicalTrials.gov Identifier:
NCT00844389
First received: February 13, 2009
Last updated: September 30, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Open Angle Glaucoma
Device: Near to infrared light retinal stimulation
Device: Green light stimulation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy

Resource links provided by NLM:


Further study details as provided by Universidad de Valparaiso:

Primary Outcome Measures:
  • Pattern electroretinogram response [ Time Frame: Every two weeks for 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OCT ganglion cell layer average thickness, Visual Field defects [ Time Frame: Every month for four months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Tatiana Cevo, Universidad de Valparaíso
ClinicalTrials.gov Identifier: NCT00844389     History of Changes
Other Study ID Numbers: ACT45-GLAUC
Study First Received: February 13, 2009
Last Updated: September 30, 2009
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

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

ClinicalTrials.gov processed this record on April 23, 2014