Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000442909
Ethics application status
Not yet submitted
Date submitted
18/04/2011
Date registered
29/04/2011
Date last updated
21/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
2RT laser trabeculoplasty vs selective laser trabeculoplasty : a prospective randomised clinical pilot study
Scientific title
2RT laser trabeculoplasty vs selective laser trabeculoplasty : a prospective randomised clinical pilot study to reduce intraocular pressure (IOP) in adults with unsatisfactorily controlled Primary Open-Angle Glaucoma (POAG)
Secondary ID [1] 260022 0
Protocol No 2N10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 265682 0
Condition category
Condition code
Eye 265820 265820 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project endeavours to establish whether treatment with a new laser (a retinal regeneration or 2RT laser), is as, or is more effective than an selective laser trabeculoplasty (or SLT) laser at for treating glaucoma. The SLT laser procedure is routinely used to treat glaucoma in a painless outpatient procedure. Our research will compare the more recent 2RT Laser with an older SLT laser but will be used in an identical manner to an selective laser trabeculoplasty procedure.

The treatment is a simple outpatient procedure which delivers nanosecond laser pulses of 532nm green laser light to the trabecular meshwork sufficient to trigger a cascade of cell destruction, replacement and trabecular meshwork remodelling; the end result leading to increased outflow for the intraocular fluid and eventual decrease in intraocular pressure to safer levels.

In practice with the SLT laser this light intensity is carefully titrated for each individual patient dependant on the individual level of pigmentation of the trabecular meshwork. The treatment model assumes a good level of uniformity of light intensity across the treatment spot. In practice this uniformity is not easy to achieve but fortunately due to the net like structure of the meshwork this tissue tolerates the lack of ideal uniformity quite well. Recent advances made, principally in the development of the 2RT laser which is designed for treating more sensitive planar tissue structures being that of the retina, result in the ability to generate a far more uniform controlled beam intensity profile.

Patients in both groups (2RT and SLT lasers) will undergo exactly the same procedure. This involves 2 sessions of laser one week apart as per routine practice. No further laser procedures are required unless the patient has not had a satisfactory outcome. Further laser can be performed if necessary. This decision will be determined by the principle investigator.

The patient will be asked to come for a pre-laser treatment visit for measurements. The first of two laser treatments will be given at that time. Prior to the treatment, eye drops are administered to prepare the eye and provide mild anaesthesia. Then, gentle pulses of light are delivered through a specially designed microscope (SLT laser). The entire process takes just a few minutes. When it’s complete, the physician may treat the eye with anti-inflammatory eye drops. A second laser treatment will be applied to the same eye around a week later. The effect of the laser on your eye pressure will be measured a month following the treatment as per routine follow up procedures.
Intervention code [1] 264443 0
Treatment: Devices
Comparator / control treatment
The control treatment is the use of selective laser trabeculoplasty (SLT) for the reduction of IOP. SLT is considered a standard surgical treatment for the reduction of IOP.

The patient will be asked to come for a pre-laser treatment visit for measurements. The first of two laser treatments will be given at that time. Prior to the treatment, eye drops are administered to prepare the eye and provide mild anaesthesia. Then, gentle pulses of light are delivered through a specially designed microscope (SLT laser). The entire process takes just a few minutes. When it’s complete, the physician may treat the eye with anti-inflammatory eye drops. A second laser treatment will be applied to the same eye around a week later. The effect of the laser on your eye pressure will be measured a month following the treatment as per routine follow up procedures.
Control group
Active

Outcomes
Primary outcome [1] 266575 0
1. the comparison of the percentage change in IOP reduction in each group;(standard Ellex SLT laser vs. new 2RT laser)
Timepoint [1] 266575 0
1 month
Secondary outcome [1] 276047 0
2. the comparison of the percentage who show a significant IOP change (responders) in each group
Timepoint [1] 276047 0
1 month

Eligibility
Key inclusion criteria
Male or female with unsatisfactorily controlled POAG
Aged 40 years or more
Are due to receive laser trabeculoplasty as part of their standard conventional glaucoma management
No participation of the patient in other studies
Must be able to fully understand the nature of the trial,including risks, and sign an informed consent as an informed volunteer
Willingness and ability of patient to participate in all follow-up examinations
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous Laser Trabeculoplasty treatment
Narrowing of the drainage angle sufficient to preclude adequate gonioscopy
Media opacity that results in an unclear view of the trabecular meshwork
Any disease process or malformation that blocks the angle of the anterior chamber
Inflammatory or uveitic glaucoma
Steroid induced glaucoma

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)
Patients will undergo tests to ensure that criteria is met for the trial. Following this the principal investigator will discuss the all suitable options with the patient. If the patient is happy to proceed onto the study the consent process will be completed. Following consent the patient will be randomized to either group.

Allocation to either group involves contacting the holder of the allocation schedule who is 'off-site' or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be undertaken by the use of simple block randomization software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 264912 0
Self funded/Unfunded
Name [1] 264912 0
Dr Nandor Jaross
Country [1] 264912 0
Australia
Primary sponsor type
Individual
Name
Dr Nandor Jaross
Address
Vision Eye Institute
97 Bell St
Coburg VIC 3058
Country
Australia
Secondary sponsor category [1] 266377 0
Commercial sector/Industry
Name [1] 266377 0
Ellex R&D Pty Ltd
Address [1] 266377 0
82 Gilbert Street Adelaide South Australia 5000
Country [1] 266377 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266870 0
Bellberry HREC
Ethics committee address [1] 266870 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 266870 0
Australia
Date submitted for ethics approval [1] 266870 0
20/02/2013
Approval date [1] 266870 0
Ethics approval number [1] 266870 0
2N10

Summary
Brief summary
This study represents a pilot study which aims to compare the effectiveness of a new laser (Ellex 2RT) to a conventional laser (SLT) in the treatment of primary open-angle glaucoma. It is expected that the Ellex 2RT laser should provide comparable or better results than the conventional SLT laser because of the more homogenous beam profile of the new laser. Results may form the basis for further clinical investigation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32508 0
Dr Nandor Jaross
Address 32508 0
Vision Eye Institute Coburg
97 Bell Street Coburg
Victoria 3058
Country 32508 0
Australia
Phone 32508 0
61 3 9354 8611
Fax 32508 0
61 3 9354 9136
Email 32508 0
[email protected]
Contact person for public queries
Name 15755 0
Dr Nandor Jaross
Address 15755 0
Vision Eye Institute
97 Bell Street
Coburg Vic 3058
Country 15755 0
Australia
Phone 15755 0
61 3 9354 8611
Fax 15755 0
61 3 9354 9136
Email 15755 0
[email protected]
Contact person for scientific queries
Name 6683 0
Dr Nandor Jaross
Address 6683 0
Vision Eye Institute
97 Bell Street
Coburg Vic 3058
Country 6683 0
Australia
Phone 6683 0
61 3 9354 8611
Fax 6683 0
61 3 9354 9136
Email 6683 0
[email protected]

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

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