Overview

This trial is active, not recruiting.

Condition open angle glaucoma
Treatments near to infrared light retinal stimulation, green light stimulation
Phase phase 0
Sponsor Universidad de Valparaiso
Collaborator Comisión Nacional de Investigación Científica y Tecnológica
Start date April 2009
End date December 2009
Trial size 40 participants
Trial identifier NCT00844389, ACT45-GLAUC

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Group of patients stimulated with near to infrared light daily stimulation
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)
Group of patients stimulated with green light.
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 Outcomes

Measure
Pattern electroretinogram response
time frame: Every two weeks for 4 months

Secondary Outcomes

Measure
OCT ganglion cell layer average thickness, Visual Field defects
time frame: Every month for four months

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy
Principal investigator Tatiana E Cevo, M.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Universidad de Valparaiso.