None listed
Conditions
Brief summary
To conduct a prospective, randomized, double-masked pilot study testing the hypothesis that near-infrared (NIR) laser acts as a neurorecoverant and improves contrast sensitivity in glaucoma patients. This is a pilot study designed to provide motivation (or not) to proceed to further research. It would be inappropriate to proceed without a pilot study of this nature. WHAT IS THE PURPOSE OF THE STUDY? We are trying to assess the effectiveness of a new type of low-energy laser. This laser is currently being studied in diabetic eye disease and we believe that it may be effective in glaucoma. The laser improves the energy supply to sick nerve cells at the back of the eye, especially those affected by glaucoma. We are hoping that this laser may actually improve vision in glaucoma. It is a very safe laser and if successful is likely to be used in conjunction with eye pressure lowering treatment. The purpose of this study is to establish a proof of a principle known as neuroprotection. Neuroprotection: refers to the ability to directly promote survival of the optic nerve. The optic nerve is the nerve that transmits visual information from the retina to the brain. Contrast sensitivity: is the ability to differentiate between light and dark (contrast). This study is to assess whether low doses of Near Infrared (NIR) laser light are beneficial in improving contrast sensitivity in glaucoma patients. Lasers are routinely used and are approved in Australia for treating a variety of eye diseases these lasers are called Thermal Lasers and are usually green in colour. They are applied to the retina through a special type of microscope and many laser spots are individually placed over the affected area. In all cases, these lasers work by burning small areas of the retina in order to trigger the required healing response that, with time, decreases the amount and extent of the swelling. We are trying to assess the effectiveness of a new type of NIR laser that is about 100 times lower in power density than a Thermal Laser. The NIR laser causes no burn; however, it appears to stimulate a healing response to injured cells and reduces edema and enhances cellular function. Hypothesis NIR laser improves contrast sensitivity in glaucoma patients
Interventions
Materials/Procedures/Delivery/Mode
The Laser Device: NEAR INFRARED LIGHT PHOTOBIOMODULATION
laser. Product names is ELLEX Integre laser
The Ellex Integre NIR Laser is a slit lamp microscope mounted 670nm light source that can be varied in brightness by the operator to set the required power density from 50 to 500 mw per square centimetre. This level is between 1x and 10x the brightness of the NIR LED device used in a similar study but even at the highest level of intensity is only just comparab
Materials/Procedures/Delivery/Mode The Laser Device: NEAR INFRARED LIGHT PHOTOBIOMODULATION laser. Product names is ELLEX Integre laser The Ellex Integre NIR Laser is a slit lamp microscope mounted 670nm light source that can be varied in brightness by the operator to set the required power density from 50 to 500 mw per square centimetre. This level is between 1x and 10x the brightness of the NIR LED device used in a similar study but even at the highest level of intensity is only just comparable to the energy density of the aiming laser used in a standard thermal laser photocoagulator. At its highest brightness this is 50X lower in energy density than a photocoagulator. As an additional safety measure the Ellex Integre NIR laser beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter in order to avoid illuminating the central macula with light. The Ellex Integre NIR Laser system has a user selectable exposure duration control permitting the user to pre-set the treatment time duration. The laser treatment will occur x 3 occasions in one week. Monday, Wednesday and Friday. The laser treatment is for 90 seconds. The procedure will require the patient to be seated at the slit lamp for laser delivery. The treatment eye will be dilated with dilating drops and anaesthetized with topical amethocaine drops. Operator/s The principal Investigator and sub Investigators are all familiar with the device and study protocol. They will be treating the subjects. The Principal investigator is an Ophthalmologist and the sub Investigators will all be Ophthalmologists or Doctors on the ophthalmology training programme. Location of area being treated The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. Therefore the central macular will be spared with only treating the affected retina.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 50 years or older • moderate to severe glaucoma (MD < -6) • Visual acuity logMAR < 1.0
Exclusion criteria
• Significant retinal disease • Severe media opacity • Patient has a condition or is in a situation that in the investigator’s opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study
Outcome results
None listed