Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000720910
Ethics application status
Approved
Date submitted
7/07/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Glaucoma Initial Treatment Study (GITS): a comparison of eye drops versus laser treatment
Scientific title
In adults with Primary Open Angle Glaucoma or PseudoExfoliation Glaucoma, a comparison of Selective Laser Trabeculoplasty with Topical Medication for Quality of Life and Cost-effectiveness outcomes: A Multi-Centre, Prospective and Randomized Controlled Clinical Trial.
Secondary ID [1] 262584 0
Nil
Universal Trial Number (UTN)
U1111-1122-6911
Trial acronym
GITS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Open Angle Glaucoma 268251 0
Pseudo Exfoliative Glaucoma 268252 0
Condition category
Condition code
Eye 268401 268401 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Selective Laser Trabeculoplasty(SLT): this procedure will use frequency doubled, 1-switched Nd:Yag lasers emitting at 532nm with a pulse duration of 3ns, spot size of 400um and pulse energies ranging from 0.2-1.7mJ, coupled to a slit delivery system with a helium-neon laser (HeNe) aiming system and any mirrored gonio lens that doesn't magnify for all patients randomised to SLT treatment. The laser will be focused on the trabecular meshwork using the HeNe aiming beams and a single laser pulse will be delivered at the 3 o'clockposition. The laser energy will be increased or reduced by 0.1mJ increments until fine 'champagne' bubbles are generated. Initial 180 degrees treatments of approximately 50 applicaiton will be applied. There can be up to 3 SLT treatments administered during the trial depending on the IOP response to treatment. Each procedure will take approximately 30-40 minutes.
Intervention code [1] 266916 0
Treatment: Devices
Intervention code [2] 266942 0
Treatment: Surgery
Intervention code [3] 266943 0
Treatment: Other
Comparator / control treatment
The following types of Ocular Hypotensive eyedrops will be able to be prescribed to those subjects randomised to the topical medication arm:Prostaglandin analogues 1 drop per day (Latanoprost/Xalatan 0.005%, Bimatoprost/Lumigan 0.03%, Travoprost/Travatan 0.004%), beta-blockers 1 drop twice daily (Betagan 2.5mg per mL/5mg per mL, Betoptic 0.25%/0.5%, Tenopt/Timolol 0.25%, 0.5%), alpha-agonists 1 drop twice daily ( Alphagan 0.15%/0.2%), Carbonic anhydrase inhibitors 1 drop twice daily (Azopt 1%, Trusopt 2%), combination eyedrops 1 drop twice daily (combigan 0.2%/0.5%, Cosopt (2%/0.5%, Duotrav (0.004%/0.5%), Xalacom (0.005%/0.5%). All drops will be adminstered indefinitely unless response to treatment is not adequate or side effects not tolerated.
Control group
Active

Outcomes
Primary outcome [1] 269158 0
Quality of Life scores as assessed by Glaucoma Quality of Life-15 Score, VisQoL Vision-Related Utility Instrument
Score, Quality of Life 36 questionnaire scores
Timepoint [1] 269158 0
6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation
Primary outcome [2] 269159 0
Costeffectiveness analysis using in-trial cost and effectiveness measures including IOP reduction and glaucoma progression.
Costs assessed will include direct costs such as costs to the patient for the consultations, procedures, eyedrops, and also indirect costs to patients and to society such as lost work productivity, costs to carers. These are assessed through the use of questionnaires including quality of life questionnaires and health services expenditure questionnaires and also through the keeping of expenses diaries and receipts by the patient and the service provider.
Timepoint [2] 269159 0
6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation
Secondary outcome [1] 279038 0
Intraocular Pressure Reduction as measure by Goldmann tonometry compared to Baseline measurement
Timepoint [1] 279038 0
6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation
Secondary outcome [2] 279046 0
Safety outcomes as measured by surgical complications, ocular surface disorders, Intraocular pressure of >30mmHG or >30% increase, visual acuity, progression of visual field loss, optic disc changes, development of uveitis, anterior chamber reaction interms of cells and flares.
Timepoint [2] 279046 0
6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation

Eligibility
Key inclusion criteria
Age - minimum 35 years; Newly diagnosed, previously untreated patients with either primary open angle glaucoma or pseudo-exfoliation glaucoma that, in the investigators opinion, warrants treatment; IOP greater or equal to 18mmHg but less than 40mmHg in at least one eye on 2 consecutive visits; Visual Field – mean deviation (MD) values less than -12 dB at baseline; Written informed consent has been obtained.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History or evidence of glaucoma other than primary open angle glaucoma, or pseudo-exfoliation glaucoma; Advanced glaucomatous field loss with MD > -12dB; History of topical or systemic ocular antihypertensive medication usage; Previous intraocular surgery (including glaucoma laser or glaucoma surgery), with the exception of uncomplicated phacoemulsification; Iridotrabecular drainage angle anomalies; Evidence of moderate non-proliferative diabetic retinopathy or worse, neovascularization or rubeosis iridis; Current use of a systemic corticosteroid, epinephrine or clonidine; Patients, who in the opinion of the investigator, will not respond adequately to treatment or who may require glaucoma surgery within the two years of study follow up; Patients who are pregnant or currently breastfeeding; Patient, who 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)
Allocation to Intervention will be random and concealed via a central telephone randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4229 0
2000
Recruitment postcode(s) [2] 4225 0
3000
Recruitment postcode(s) [3] 4226 0
3065
Recruitment postcode(s) [4] 4227 0
4101
Recruitment postcode(s) [5] 4228 0
5006

Funding & Sponsors
Funding source category [1] 267399 0
Government body
Name [1] 267399 0
National Health and Medical Research Council
Country [1] 267399 0
Australia
Primary sponsor type
Other
Name
Centre for Eye Research Australia
Address
32 Gisborne Street East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 266456 0
None
Name [1] 266456 0
Address [1] 266456 0
Country [1] 266456 0
Other collaborator category [1] 252091 0
Individual
Name [1] 252091 0
Dr. Ivan Goldberg
Address [1] 252091 0
Park House Level 4, 187 Macquarie St
Sydney NSW 2000
Country [1] 252091 0
Australia
Other collaborator category [2] 252092 0
Individual
Name [2] 252092 0
Prof Robert Casson
Address [2] 252092 0
Harley Eye Clinic 63 Palmer Pl, North Adelaide SA 5006.
Country [2] 252092 0
Australia
Other collaborator category [3] 252093 0
Other
Name [3] 252093 0
Queensland Eye Institute
Address [3] 252093 0
41 Annerley Raod South Brisbane QLD 4101
Country [3] 252093 0
Australia
Other collaborator category [4] 252094 0
University
Name [4] 252094 0
Flinders University
Address [4] 252094 0
School of Medicine
Flinders University
GPO Box 2100, Adelaide 5001, South Australia
Country [4] 252094 0
Australia
Other collaborator category [5] 252095 0
University
Name [5] 252095 0
Duke-NUS Graduate Medical School Singapore
Address [5] 252095 0
Duke-NUS Graduate Medical School Singapore
8 College Road
Singapore 169857
Country [5] 252095 0
Singapore
Other collaborator category [6] 252096 0
Hospital
Name [6] 252096 0
Westmead Hospital - Prof Paul Healey
Address [6] 252096 0
Ophthalmology Clinics,
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145
Country [6] 252096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269364 0
Royal Victorian Eye and Ear Hospital Human Research Ethics Committee
Ethics committee address [1] 269364 0
32 Gisborne Street East Melbourne VIC 3002
Ethics committee country [1] 269364 0
Australia
Date submitted for ethics approval [1] 269364 0
06/06/2011
Approval date [1] 269364 0
27/06/2011
Ethics approval number [1] 269364 0
11/1024H

Summary
Brief summary
The primary aims of this study are to determine the effectiveness of selective laser trabeculoplasty (SLT)
with topical medication therapy in the treatment of early Glaucoma with regards to Quality of Life and
Cost-effectiveness. The study also aims to determine factors associated with the outcomes of these two
therapies, such as pre-treatment IOP and compare the safety and efficacy of the two therapies.
Two groups of patients will be recruited for the study:
1) patients with a diagnosis of Primary Open Angle Glaucoma who have not previously received treatment
for this and;
2) patients with a diagnosis of Pseudo-exfoliative Glaucoma who have not previously received treatment.
Patients will be asked to undergo a Quality of Life Questionnaire Interview over the telephone and will be
asked to provide information on the costs related to their health care, treatment of their glaucoma and
attendance at appointments. They will also be clinically examined where information including their
intraocular pressures, visual fields, optic discs and visual acuity will be recorded. They will also be asked to
provide information relating to their ethnicity, level of education, date of birth, employment status and
medical history. Participants will be randomized to either receive Selective laser Trabeculoplasty or Topical
eye drops at the Baseline visit. They will then be seen every 6 months for 2 years. If in the first 6 months,
however, they do not achieve a 25% reduction in Intraocular Pressure from baseline levels, they will be seen
6 weekly until this is achieved. Analysis of the data will be on an intention to treat basis where participant
outcomes will be analysed according to the group they were randomised rather than the actual treatment
they received. The types of analysis to be performed includes Rasch analysis of the Quality of Life
questionnaire responses, Cost Effectiveness analysis, multivariable regression models and generalised
estimating equations. This study addresses novel outcomes that have previously not been addressed
before, including taking into account the patients perspective by examining the impact of the two types of
treatment on patients quality of life and also the cost of the two treatments, both to the patient and to
society.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32843 0
Address 32843 0
Country 32843 0
Phone 32843 0
Fax 32843 0
Email 32843 0
Contact person for public queries
Name 16090 0
Rachel McIntosh
Address 16090 0
Centre for Eye Research Australia
32 Gisborne Street East Melbourne VIC 3002
Country 16090 0
Australia
Phone 16090 0
+61 3 9929 8075
Fax 16090 0
+61 3 9929 8030
Email 16090 0
rlmck@unimelb.edu.au
Contact person for scientific queries
Name 7018 0
Rachel McIntosh
Address 7018 0
Centre for Eye Research Australia
32 Gisborne Street East Melbourne VIC 3002
Country 7018 0
Australia
Phone 7018 0
+61 3 9929 8075
Fax 7018 0
+61 3 9929 8030
Email 7018 0
rlmck@unimelb.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
SourceTitleYear of PublicationDOI
EmbaseComparing the effectiveness of selective laser trabeculoplasty with topical medication as initial treatment (the Glaucoma Initial Treatment Study): Study protocol for a randomised controlled trial.2015https://dx.doi.org/10.1186/s13063-015-0924-6
EmbaseSelective laser trabeculoplasty versus topical medication as initial glaucoma treatment: The glaucoma initial treatment study randomised clinical trial.2020https://dx.doi.org/10.1136/bjophthalmol-2018-313396
N.B. These documents automatically identified may not have been verified by the study sponsor.