Open Angle GlaucomaEarly Phase 1NCT00844389
Near to Infrared (NIR) Light Neuroprotection in Glaucomatous Optic Neuropathy
A Early Phase 1 study testing Near to infrared light retinal stimulation and Green light stimulation in people with Open Angle Glaucoma, run by Universidad de Valparaiso at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Near to infrared light retinal stimulation and Green light stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- Apr 2009to Mar 2010
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
- Refractive error of 3 diopters or more
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy
The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.
Read the 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.
- Conditions
- Open Angle Glaucoma
- Being tested
- Near to infrared light retinal stimulation, Green light stimulation
- Keywords
- Open Angle Glaucoma, Biophotomodulation, Near to Infrared light stimulation, Neuroprotection
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near to infrared light retinal stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NIR light | Active comparator | Group of patients stimulated with near to infrared light daily stimulation Receives: Device: Near to infrared light retinal stimulation |
| Green light | Placebo comparator | Group of patients stimulated with green light. Receives: Device: Green light stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern electroretinogram response
Measured: Every two weeks for 4 months
Secondary outcomes (1)
OCT ganglion cell layer average thickness, Visual Field defects
Measured: Every month for four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Investigators
- Tatiana E Cevo, M.D, Principal investigator, Universidad de ValparaisoAdrian Palacios, PhD, Study director, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844389
- Sponsor's protocol ID
- ACT45-GLAUC
- Status last verified
- Sep 2009
- First submitted
- 13 Feb 2009
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near to Infrared Light Stimulation Effect on Ganglion Cell Function in Glaucomatous Optic Neuropathy
- ClinicalTrials.gov ID
- NCT00844389
- Acronym / sponsor ID
- ACT45-GLAUC
- Conditions
- Open Angle Glaucoma
- Keywords
- Open Angle Glaucoma, Biophotomodulation, Near to Infrared light stimulation, Neuroprotection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 16 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate if near-to-infrared light stimulation can improve retinal ganglion cell function in glaucomatous patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIR light | Active comparator | Device: Near to infrared light retinal stimulationGroup of patients stimulated with near to infrared light daily stimulation |
| Green light | Placebo comparator | Device: Green light stimulationGroup of patients stimulated with green light. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Diabetic retinopathy, Multiple Sclerosis, Parkinson disease
- Refractive error of 3 diopters or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near to infrared light retinal stimulationPatients 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. | Device | NIR light |
| Green light stimulationPatients 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. | Device | Green light |
Primary outcome
Pattern electroretinogram response
Time frame: Every two weeks for 4 months
1 secondary outcome
OCT ganglion cell layer average thickness, Visual Field defects
Time frame: Every month for four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tatiana E Cevo, M.D principal investigator
Universidad de Valparaiso
Adrian Palacios, PhD study director
Universidad de Valparaiso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Near to infrared light retinal stimulation and Green light stimulation in people with Open Angle Glaucoma, run by Universidad de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern electroretinogram response (time frame: Every two weeks for 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2009; AzTrials last refreshed its copy on 8 Nov 2026.