Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000651280
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
24/04/2018
Date last updated
14/10/2021
Date data sharing statement initially provided
14/10/2021
Date results information initially provided
14/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of low level laser therapy on vision in patients with retinitis pigmentosa
Scientific title
The effect of photobiomodulation on visual acuity in retinitis pigmentosa
Secondary ID [1] 294194 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinitis pigmentosa 306827 0
Condition category
Condition code
Eye 305934 305934 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 306222 306222 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients to be treated with 90 seconds of low level laser to the study eye with an Ellex Integre PBM laser that has a wave length of 670nm.
Group 1 will be treated with 25 mW/cm2 for 90 secs
Group 2 will be treated with 100mW/cm2 for 90 secs.
Treatment will take place twice a week for 4 weeks with 8 treatments in all.
All treatments will be performed by an ophthalmologist.
All of Group 1 patients to complete their 4 week post treatment review prior to commencing Group 2 with treatment.
Clinic schedules will monitor every patient attendance. Appointment letters will be sent out to all participants and a schedule of planned visit dates and times provided at their initial visit. Contact numbers of trial coordinators are available to all participants.
Month 6 visit will be scheduled via a telephone call to ensure suitable date and time is established for the participant.
Intervention code [1] 300491 0
Treatment: Devices
Comparator / control treatment
Group 1 will be control group and if no adverse events group 2 will recieve the increased dose
Control group
Dose comparison

Outcomes
Primary outcome [1] 304978 0
Primary outcome measure will be the safety profile , safety defined by the absence of adverse events.
Any experience of adverse events will be asked by the clinical trial coordinator at each visit the patient has, with the responses documented in the patient notes.
Contact details will be provided to the patients should they need to report any adverse events outside of these visits.
CTCAE will be used to grade any serious adverse events by the ophthalmologists reviewing the patients.
Timepoint [1] 304978 0
4 weeks and 6 month safety review
Secondary outcome [1] 343785 0
Secondary outcome variable will be the difference between measurements of Autorefracton carried out at baseline to the repeat of these after the PBM.
Refractive error to be measured using autorefractor.
Timepoint [1] 343785 0
4 weeks and 6 month safety follow up
Secondary outcome [2] 345292 0
Secondary outcome variable will be the difference between measurements of visual acuity carried out at baseline to the repeat of these after the PBM.
To be measured using logmar visual acuity test.
Timepoint [2] 345292 0
4 weeks and 6 month safety follow up
Secondary outcome [3] 345293 0
Secondary outcome variable will be the difference between measurements of contrast sensitivity testing carried out at baseline to the repeat of these after the PBM.
To be measured using CSV - 1000 system
Timepoint [3] 345293 0
4 weeks and 6 month safety follow up
Secondary outcome [4] 345294 0
Secondary outcome variable will be the difference between measurements of cataract grading carried out at baseline to the repeat of these after the PBM.
To be measured using LOCs grading system
Timepoint [4] 345294 0
4 weeks and 6 month safety follow up
Secondary outcome [5] 345295 0
Secondary outcome variable will be comparison of fundus photos taken at baseline to the repeat of these after the PBM.
The macula will be assessed and documented as seen clinically at baseline and follow up for comparison.
Timepoint [5] 345295 0
4 weeks and 6 month safety follow up
Secondary outcome [6] 345296 0
Secondary outcome variable will be comparison of OCT images taken at baseline to the repeat of these after the PBM.
The macula thickness will be documented for comparison.
Timepoint [6] 345296 0
4 weeks and 6 month safety follow up
Secondary outcome [7] 345297 0
Secondary outcome variable will be comparison of slit lamp examination taken at baseline to the repeat of these after the PBM.
Anterior segment inflammation will be documented as clinically seen for comparison at each visit.
Timepoint [7] 345297 0
4 weeks and 6 month safety follow up
Secondary outcome [8] 345298 0
Secondary outcome variable will be the difference between measurements of ERG testing carried out at baseline to the repeat of these after the PBM.
To be measured using RETEVAL device
Timepoint [8] 345298 0
4 weeks and 6 month safety follow up

Eligibility
Key inclusion criteria
• Age 18 years or older
• Visual acuity between 6/12 and 6/240 (letters 77 – 4) and the decreased vision is attributed to RP and not explained by any other cause
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any eye with an intraocular surgical or laser procedure within 6 months
• 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

• Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using reliable means of contraception. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or is surgically sterilised

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase 1 interventional study
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size has principally been determined to provide a reasonable sample of patients such that any adverse events are likely to be demonstrated over both “dose” settings. However, for the secondary outcome of change in visual acuity, based on our laboratory data we are estimating an improvement in visual acuity of 9 letters with a standard deviation of 6 letters. For a power of 0.8 and alpha of 0.05 and a paired t-test comparing baseline and follow-up acuity, a sample size of 12 is required. We will pool the results from both dose settings; hence, 12 patients (eyes) total provides a suitable sample size to obtain meaningful results on efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2018
Actual
10/09/2018
Date of last participant enrolment
Anticipated
11/05/2020
Actual
31/10/2019
Date of last data collection
Anticipated
19/10/2020
Actual
14/05/2020
Sample size
Target
6
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 10240 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 21905 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 298827 0
Hospital
Name [1] 298827 0
The Royal Adelaide Hospital
Country [1] 298827 0
Australia
Primary sponsor type
Hospital
Name
The Royal Adelaide Hospital
Address
Port Road,
Adelaide, 5000,
SA
Country
Australia
Secondary sponsor category [1] 298023 0
None
Name [1] 298023 0
Address [1] 298023 0
Country [1] 298023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299774 0
Royal Adelaide Hospital
Ethics committee address [1] 299774 0
Level 3, Roma Mitchell House,
136 North Terrace,
Adelaide
SA
5000
Ethics committee country [1] 299774 0
Australia
Date submitted for ethics approval [1] 299774 0
12/03/2018
Approval date [1] 299774 0
08/05/2018
Ethics approval number [1] 299774 0

Summary
Brief summary
This study is to assess whether photobiomodulation is beneficial in treating Retinitis Pigmentosa (RP). Photobiomodulation is a low level laser therapy that is used to treat varying conditions by stimulating cell functioning. Lasers are routinely used and are approved in Australia for treating differing eye conditions. 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 for the affected cells.
We are trying to assess the effectiveness of a new type of Near Infrared (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, including blood vessels and neurons in the retina, resulting in a protective effect on cone cells. This treatment is not yet approved for use in Australia, although it has been tested in research studies overseas.
The purpose of the trial is to determine if NIR laser has an acceptable safety profile to treat patients with RP.
The study will last for approximately 6 months with up to 11 study visits. Each visit will take up to 1 hour depending on the assessments involved.
There will be a total of 2 laser treatments within a 1 week period for 4 weeks. After the completion of the laser treatment there will be a visit 4 weeks later to repeat the same checks as the baseline visit, and again at 6 months.
This is a research study, and NIR Laser therapy is not registered for use in patients with RP in Australia at the present time and may never be registered. If this treatment becomes registered, then it may not be subsidised by the Medicare Benefit Scheme (PMBS) in Australia. The Investigators cannot commit at this stage to provide this as ongoing treatment after the study is over.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81526 0
Prof Robert Casson
Address 81526 0
Ophthalmology Network,
Room 6G-462,
Royal Adelaide Hospital,
Port Rd,
Adelaide,
SA,
5000
Country 81526 0
Australia
Phone 81526 0
+61 8 70742257
Fax 81526 0
Email 81526 0
[email protected]
Contact person for public queries
Name 81527 0
Mrs Mel Willoughby
Address 81527 0
Ophthalmology Network,
Room 6G-462,
Royal Adelaide Hospital,
Port Rd,
Adelaide,
SA,
5000
Country 81527 0
Australia
Phone 81527 0
+61 8 70742257
Fax 81527 0
Email 81527 0
[email protected]
Contact person for scientific queries
Name 81528 0
Prof Robert Casson
Address 81528 0
Ophthalmology Network,
Room 6G-462,
Royal Adelaide Hospital,
Port Rd,
Adelaide,
SA,
5000
Country 81528 0
Australia
Phone 81528 0
+61 8 70742257
Fax 81528 0
Email 81528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.