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Trial registered on ANZCTR


Registration number
ACTRN12617001592336p
Ethics application status
Submitted, not yet approved
Date submitted
11/10/2017
Date registered
1/12/2017
Date last updated
1/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Near-infrared Laser on Contrast Sensitivity in Human Glaucoma
(NIRG) Glaucoma Laser Study
Scientific title
The Effect of Near-infrared Laser on Contrast Sensitivity in Human Glaucoma: a prospective, randomized, double-masked pilot study
Secondary ID [1] 293155 0
none
Universal Trial Number (UTN)
Trial acronym
NIRG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 305059 0
Condition category
Condition code
Eye 304383 304383 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299356 0
Treatment: Devices
Comparator / control treatment
Control group will be treated with a sham laser.
The Sham laser will look and sound the same as the 'live' laser.
patients will receive the same set up at the slit-lamp laser except that
the infra-red laser will not be fired when the laser application foot pedal is activated.
This foot pedal makes a sound indistinguishable from actual laser delivery and the
aiming beam is also rendered indistinguishable from actual laser therapy. Hence, the
patient is genuinely masked to the nature of the treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 303628 0
Baseline contrast sensitivity will be measured using the routine CSV-1000 apparatus. The contrast sensitivity will be measured again 7 days after treatment/sham procedure and the difference between measurements will be the primary outcome variable.
Timepoint [1] 303628 0
7 days after the final treatment/placebo (the following Friday) the baseline
measurements will be repeated in the same order. The primary outcome will be the
change in the CS measurement at 12 cycles per degree compared to baseline. This
single outcome was chosen based on our previous study showing an improvement in
this parameter after glucose-induced neurorecovery and to avoid reductions in the
alpha value due to multiple hypothesis testing.
Secondary outcome [1] 339687 0
LogMAR Visual Acuity.
Timepoint [1] 339687 0
7 days after the final treatment/placebo the baseline
measurements will be repeated in the same order.
The secondary outcome LogMAR VA will be repeated in the same manner that was performed at the baseline visit.
Secondary outcome [2] 339895 0
Change in AVF (Automated Visual Field)
Timepoint [2] 339895 0
7 days after the final treatment/placebo the baseline
measurements will be repeated in the same order.
The secondary outcome AVF (Automated Visual Field) will be repeated in the same manner that was performed at the baseline visit.
Secondary outcome [3] 339896 0
Safety outcomes
Loss of Visual Acuity -
Visual Acuity will be assessed using the LogMAR visual acuity chart. A safety measure is to review and how many letters are reduced at this visit.
Timepoint [3] 339896 0
7 days after the final treatment/placebo the baseline
measurements will be repeated in the same order.
The safety outcome will be reassessed the same way they're performed at the baseline visit.
Secondary outcome [4] 340734 0
Optical Coherence Tomography (OCT)
The repeat OCT of both optic discs and macula will be assessed for any swelling, hemorrhage. It will also allow the Ophthalmologist to assess if there's any changes to the fibers of the optic nerve.
Timepoint [4] 340734 0
7 days after the final treatment/placebo the baseline
measurements will be repeated in the same order.
The safety outcome will be reassessed the same way they're performed at the baseline visit.

Eligibility
Key inclusion criteria
• Age 50 years or older
• moderate to severe glaucoma (MD < -6)
• Visual acuity logMAR < 1.0
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
a pilot, prospective randomized, double-masked study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The design is a randomized double-masked study using a mixed linear model for analysis to account for correlation between the two eyes in patients were both eyes are eligible. The eye is the unit of analysis.
The sample size calculation was based on results from our previous study. Assuming a treatment effect of a 0.26 log unit improvement in contrast sensitivity with a standard deviation of 0.34 log units, a correlation of 0.7 between eyes in the same patient, a power of 0.8 and alpha at 0.05, then 14 eyes are required in each group. Allowing for possible loss to follow-up, we will recruit a total of 32 eyes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/12/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9177 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 17813 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 297740 0
Self funded/Unfunded
Name [1] 297740 0
Professor Robert Casson
Country [1] 297740 0
Australia
Funding source category [2] 298053 0
Commercial sector/Industry
Name [2] 298053 0
Ellex Pty Ltd Laser equipment
Country [2] 298053 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Port Road
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 297125 0
None
Name [1] 297125 0
Address [1] 297125 0
Country [1] 297125 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298803 0
Royal Adelaide Hospital
Ethics committee address [1] 298803 0
CALHN HUMAN RESEARCH ETHICS
RAH:
Royal Adelaide Hospital | Level 4 | Women’s Health Centre
North Terrace, Adelaide, SA 5000
Ethics committee country [1] 298803 0
Australia
Date submitted for ethics approval [1] 298803 0
11/10/2017
Approval date [1] 298803 0
Ethics approval number [1] 298803 0

Summary
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

Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2106 2106 0 0
/AnzctrAttachments/373804-NIRG Trial Protocol V1 13th Sep 2017 R Casson.pdf
Attachments [2] 2107 2107 0 0
/AnzctrAttachments/373804-NIRG Glaucoma PIF R Casson V1 13th Sep 2017.pdf (Participant information/consent)

Contacts
Principal investigator
Name 78274 0
Prof Robert Casson
Address 78274 0
Ophthalmology Network
Room 6G-462
Royal Adelaide Hospital
Port Road, ADELAIDE SA 5000
Country 78274 0
Australia
Phone 78274 0
+61 8 70742254
Fax 78274 0
Email 78274 0
robert.casson@adelaide.edu.au
Contact person for public queries
Name 78275 0
Ms Kylie Dansie
Address 78275 0
Ophthalmology Network
Room 6G-462
Royal Adelaide Hospital
Port Road, ADELAIDE SA 5000
Country 78275 0
Australia
Phone 78275 0
+61 8 70742254
Fax 78275 0
Email 78275 0
kylie.dansie@health.sa.gov.au
Contact person for scientific queries
Name 78276 0
Prof Robert Casson
Address 78276 0
Ophthalmology Network
Room 6G-462
Royal Adelaide Hospital
Port Road, ADELAIDE SA 5000
Country 78276 0
Australia
Phone 78276 0
+61 8 70742254
Fax 78276 0
Email 78276 0
robert.casson@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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