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NCT00844389 Clinical Trial

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

Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00844389
Other study ID # ACT45-GLAUC
Secondary ID
Status Active, not recruiting
Phase Phase 0
First received February 13, 2009
Last updated September 30, 2009
Start date April 2009
Est. completion date March 2010

Study information
Verified date September 2009
Source Universidad de Valparaiso
Contact n/a
Is FDA regulated No
Health authority Chile: Comisión Nacional de Investigación Científica y Tecnológica
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date March 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Chile Servicio de Oftalmología Hospital Van Buren Valparaiso

Sponsors (2)
Lead Sponsor Collaborator
Universidad de Valparaiso Comisión Nacional de Investigación Científica y Tecnológica

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pattern electroretinogram response Every two weeks for 4 months No
Secondary OCT ganglion cell layer average thickness, Visual Field defects Every month for four months No
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