Glaucoma Initial Treatment Study (GITS): a comparison of eye drops versus laser treatment

Not Applicable

• Conditions: Primary Open Angle Glaucoma; Pseudo Exfoliative Glaucoma; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12611000720910
• Lead Sponsor: Centre for Eye Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 400

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life scores as assessed by Glaucoma Quality of Life-15 Score, VisQoL Vision-Related Utility Instrument<br>Score, Quality of Life 36 questionnaire scores[6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation];Costeffectiveness analysis using in-trial cost and effectiveness measures including IOP reduction and glaucoma progression.<br>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.[6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation]

Secondary Outcome Measures

Name	Time	Method
Intraocular Pressure Reduction as measure by Goldmann tonometry compared to Baseline measurement[6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation];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.[6 weeks post randomisation, 6 months post randomisation, 12 months post randomisation, 18 months post randomisation, 24 months post randomisation]