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
Recruitment status was Active, not recruiting
Sponsor:
Universidad de Valparaiso
Collaborator:
Chile: 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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
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
Chile: 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 May 21, 2013