None listed
Conditions
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.
Interventions
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 s
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.
Sponsors
The Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed