ANZCTR - Registration

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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]

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

Pseudo Exfoliative Glaucoma

Condition category

Condition code

Eye

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]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Intervention code [3]

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]

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]

6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation

Primary outcome [2]

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]

6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation

Secondary outcome [1]

Intraocular Pressure Reduction as measure by Goldmann tonometry compared to Baseline measurement

Timepoint [1]

6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation

Secondary outcome [2]

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]

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?

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]

3000

Recruitment postcode(s) [2]

3065

Recruitment postcode(s) [3]

4101

Recruitment postcode(s) [4]

5006

Recruitment postcode(s) [5]

2000

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421. Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr. Ivan Goldberg

Address [1]

Park House Level 4, 187 Macquarie St
Sydney NSW 2000

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Prof Robert Casson

Address [2]

Harley Eye Clinic 63 Palmer Pl, North Adelaide SA 5006.

Country [2]

Australia

Other collaborator category [3]

Other

Name [3]

Queensland Eye Institute

Address [3]

41 Annerley Raod South Brisbane QLD 4101

Country [3]

Australia

Other collaborator category [4]

University

Name [4]

Flinders University

Address [4]

School of Medicine
Flinders University
GPO Box 2100, Adelaide 5001, South Australia

Country [4]

Australia

Other collaborator category [5]

University

Name [5]

Duke-NUS Graduate Medical School Singapore

Address [5]

Duke-NUS Graduate Medical School Singapore
8 College Road
Singapore 169857

Country [5]

Singapore

Other collaborator category [6]

Hospital

Name [6]

Westmead Hospital - Prof Paul Healey

Address [6]

Ophthalmology Clinics,
Westmead Hospital
Hawkesbury Rd
Westmead NSW 2145

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Victorian Eye and Ear Hospital Human Research Ethics Committee

Ethics committee address [1]

32 Gisborne Street East Melbourne VIC 3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/06/2011

Approval date [1]

27/06/2011

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Rachel McIntosh

Address

Centre for Eye Research Australia
32 Gisborne Street East Melbourne VIC 3002

Country

Australia

Phone

+61 3 9929 8075

Fax

+61 3 9929 8030

rlmck@unimelb.edu.au

Contact person for scientific queries

Name

Rachel McIntosh

Address

Centre for Eye Research Australia
32 Gisborne Street East Melbourne VIC 3002

Country

Australia

Phone

+61 3 9929 8075

Fax

+61 3 9929 8030

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

Source	Title	Year of Publication	DOI
Embase	Comparing the effectiveness of selective laser trabeculoplasty with topical medication as initial treatment (the Glaucoma Initial Treatment Study): Study protocol for a randomised controlled trial.	2015	https://dx.doi.org/10.1186/s13063-015-0924-6
Embase	Selective laser trabeculoplasty versus topical medication as initial glaucoma treatment: The glaucoma initial treatment study randomised clinical trial.	2020	https://dx.doi.org/10.1136/bjophthalmol-2018-313396

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically