Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001021965
Ethics application status
Approved
Date submitted
2/06/2020
Date registered
8/10/2020
Date last updated
8/10/2020
Date data sharing statement initially provided
8/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The International Glaucoma Surgery Registry
Scientific title
The International Glaucoma Surgery Registry: An Observational Study of the Safety, Efficacy, and Cost-Effectiveness of Glaucoma Surgery
Secondary ID [1] 301908 0
None
Universal Trial Number (UTN)
Trial acronym
IGSR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 317708 0
Ocular Hypertension 317709 0
Condition category
Condition code
Eye 315786 315786 0 0
Diseases / disorders of the eye
Surgery 315787 315787 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The registry is a non-interventional, observational study of patients who have undergone, or are scheduled to undergo, a laser or surgical procedure for the management of glaucoma or ocular hypertension. Patients are managed according to standard of care and local procedures/policies without input from the registry. It is not anticipated that there will be any change to glaucoma management with participation in the registry.

Patients with a history of conventional glaucoma filtration surgery, minimally invasive glaucoma surgery, laser/ultrasound procedures, or other novel interventional technique for the management of glaucoma or ocular hypertension will be included in the study and followed during their active follow-up attendances. The registry will collate data collected as part of routine care and from patient-completed questionnaires.
Intervention code [1] 317738 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323994 0
The primary outcome will be the mean change in intraocular pressure from baseline measured in mmHg entered into the registry from the medical record.
Timepoint [1] 323994 0
Baseline, 12 months, 2 years, 3 years, 5 years
Primary outcome [2] 323995 0
The mean change in the number of classes of glaucoma eye drops from baseline as recorded in the registry from the medical record.
Timepoint [2] 323995 0
Baseline, 12 months, 2 years, 3 years, 5 years
Primary outcome [3] 324580 0
The proportion of patients experiencing intra- and post-operative complications as recorded in the registry from the medical record.

Intra-operative:
Anaesthetic or systemic complications
Anterior chamber haemorrhage / hyphaema
Conjunctival tear or buttonhole
Corneal epithelial defect
Inability to place device
Iris prolapse
Iris trauma
Retrobulbar haemorrhage
Rupture of trabeculo-Descemet membrane
Scleral flap problems
Severing of extraocular muscle tendon
Subconjunctival haemorrhage
Suprachoroidal haemorrhage
Vitreous prolapse

Postoperative:
5-FU keratopathy
Aqueous misdirection
Bleb dysaesthesia
Bleb encapsulation
Bleb leak
Bleb-related endophthalmitis
Blebitis without endophthalmitis
Cataract progression
Choroidal effusion
Corneal epithelial defect / ulcer
Corneal Dellen
Cystoid macular oedema
Decompression retinopathy
Descemet membrane detachment
Endophthalmitis
Flat anterior chamber
Hyphaema (10% or less of anterior chamber)
Hyphaema (> 10% anterior chamber)
Hypotony (no sequelae)
Hypotony maculopathy
Peripheral anterior synechiae formation
Persistent corneal oedema
Persistent diplopia
Prolonged intraocular inflammation / uveitis
Ptosis
Retinal detachment
Retinal vein occlusion
Retinal pathology unrelated to surgery reducing vision
Shallow anterior chamber
Suprachoroidal haemorrhage
Tube / device erosion or exposure
Tube / device obstruction
Tube / device corneal touch
Tube / device malposition
Tube / device retraction
Unintentional cyclodialysis cleft
Wound leak
Vitreous haemorrhage
Timepoint [3] 324580 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [1] 383520 0
The percentage of patients achieving a 20% reduction in intraocular pressure from baseline as recorded in the registry from the medical record.
Timepoint [1] 383520 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [2] 385034 0
The proportion of patients who are drop-free (not using glaucoma eye drops) as recorded in the registry from the medical record.
Timepoint [2] 385034 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [3] 385035 0
The proportion of patients who require a further glaucoma procedure to control intraocular pressure as recorded in the registry from the medical record.
Timepoint [3] 385035 0
12 months, 2 years, 3 years, 5 years
Secondary outcome [4] 385036 0
The proportion of patients achieving an intraocular pressure of 21 mmHg or less, 18 mmHg or less, 15 mmHg or less, and 12 mmHg or less as recorded in the registry from the medical record.
Timepoint [4] 385036 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [5] 385037 0
Mean change in visual field mean deviation in dB on automated perimetry recorded in the registry from the medical record.
Timepoint [5] 385037 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [6] 385038 0
Mean change in health-related quality of life recorded in the registry from patient questionnaires (e.g. 15D and FDA MIGS patient reported outcome measure)
Timepoint [6] 385038 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [7] 385039 0
Costs of treatment recorded in dollars as recorded in the registry from the medical record and patient questionnaires.
Timepoint [7] 385039 0
Baseline, 12 months, 2 years, 3 years, 5 years
Secondary outcome [8] 386233 0
Mean change in ocular surface disease symptoms in the registry from patient questionnaires (e.g. Ocular Surface Disease Index, OSDI)
Timepoint [8] 386233 0
Baseline, 6 months, 12 months, 2 years, 3 years, 5 years

Eligibility
Key inclusion criteria
This study will include all participants:
1. identified as having a glaucoma procedure
2. who do not opt-out of inclusion in the registry and collection of prospective and retrospective data
3. where a Waiver of Consent has been approved, retrospective data from participants who have previously undergone a glaucoma procedure and are no longer in active follow-up.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who opt-out of the study or request removal of their data from the registry.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
The registry will routinely report data quality with respect to the core dataset. This will incorporate data completeness, consistency, and validity. Registry primary and secondary outcomes will be reported bi-annually.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25000
Accrual to date
2500
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 22604 0
Algeria
State/province [1] 22604 0
Country [2] 22605 0
Armenia
State/province [2] 22605 0
Country [3] 22606 0
Austria
State/province [3] 22606 0
Country [4] 22607 0
Belgium
State/province [4] 22607 0
Country [5] 22608 0
Brazil
State/province [5] 22608 0
Country [6] 22609 0
Canada
State/province [6] 22609 0
Country [7] 22610 0
Chile
State/province [7] 22610 0
Country [8] 22611 0
Croatia
State/province [8] 22611 0
Country [9] 22612 0
Czech Republic
State/province [9] 22612 0
Country [10] 22613 0
Denmark
State/province [10] 22613 0
Country [11] 22614 0
Finland
State/province [11] 22614 0
Country [12] 22615 0
France
State/province [12] 22615 0
Country [13] 22616 0
Georgia
State/province [13] 22616 0
Country [14] 22617 0
Germany
State/province [14] 22617 0
Country [15] 22618 0
Ghana
State/province [15] 22618 0
Country [16] 22619 0
Greece
State/province [16] 22619 0
Country [17] 22620 0
Iceland
State/province [17] 22620 0
Country [18] 22621 0
India
State/province [18] 22621 0
Country [19] 22622 0
Iran, Islamic Republic Of
State/province [19] 22622 0
Country [20] 22623 0
Ireland
State/province [20] 22623 0
Country [21] 22624 0
Israel
State/province [21] 22624 0
Country [22] 22625 0
Italy
State/province [22] 22625 0
Country [23] 22626 0
Japan
State/province [23] 22626 0
Country [24] 22627 0
Jordan
State/province [24] 22627 0
Country [25] 22628 0
Korea, Republic Of
State/province [25] 22628 0
Country [26] 22629 0
Malaysia
State/province [26] 22629 0
Country [27] 22630 0
New Zealand
State/province [27] 22630 0
Country [28] 22631 0
Netherlands
State/province [28] 22631 0
Country [29] 22632 0
Norway
State/province [29] 22632 0
Country [30] 22633 0
Peru
State/province [30] 22633 0
Country [31] 22634 0
Poland
State/province [31] 22634 0
Country [32] 22635 0
Portugal
State/province [32] 22635 0
Country [33] 22636 0
Russian Federation
State/province [33] 22636 0
Country [34] 22637 0
Serbia and Montenegro
State/province [34] 22637 0
Country [35] 22638 0
Singapore
State/province [35] 22638 0
Country [36] 22639 0
South Africa
State/province [36] 22639 0
Country [37] 22640 0
Spain
State/province [37] 22640 0
Country [38] 22641 0
Sri Lanka
State/province [38] 22641 0
Country [39] 22642 0
Sweden
State/province [39] 22642 0
Country [40] 22643 0
Switzerland
State/province [40] 22643 0
Country [41] 22644 0
Thailand
State/province [41] 22644 0
Country [42] 22645 0
Trinidad and Tobago
State/province [42] 22645 0
Country [43] 22646 0
Tunisia
State/province [43] 22646 0
Country [44] 22647 0
Turkey
State/province [44] 22647 0
Country [45] 22648 0
United Kingdom
State/province [45] 22648 0
Country [46] 22649 0
United States of America
State/province [46] 22649 0
Country [47] 22650 0
Uruguay
State/province [47] 22650 0

Funding & Sponsors
Funding source category [1] 305855 0
Commercial sector/Industry
Name [1] 305855 0
Allergan LLC
Country [1] 305855 0
United States of America
Funding source category [2] 305867 0
Other Collaborative groups
Name [2] 305867 0
Ophthalmic Research Institute of Australia (ORIA)
Country [2] 305867 0
Australia
Funding source category [3] 305868 0
Commercial sector/Industry
Name [3] 305868 0
Martin-Baker
Country [3] 305868 0
United Kingdom
Primary sponsor type
Other Collaborative groups
Name
International Glaucoma Surgery Registry
Address
145 City Road
London EC1V 1AW
Country
United Kingdom
Secondary sponsor category [1] 306317 0
University
Name [1] 306317 0
Centre for Eye Research Australia
Address [1] 306317 0
Level 7/32 Gisborne Street
East Melbourne VIC 3002
Country [1] 306317 0
Australia
Other collaborator category [1] 281344 0
Individual
Name [1] 281344 0
Keith Barton (Co-principal investigator)
Address [1] 281344 0
International Glaucoma Surgery Registry
145 City Rd, Hoxton, London EC1V 1AZ, United Kingdom
Zeughausgasse, 18
ZUG Zug 6301
Country [1] 281344 0
Switzerland
Other collaborator category [2] 281505 0
Charities/Societies/Foundations
Name [2] 281505 0
European Glaucoma Society
Address [2] 281505 0
Zeughausgasse, 18
ZUG Zug 6301
Country [2] 281505 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306115 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 306115 0
Ethics committee country [1] 306115 0
Australia
Date submitted for ethics approval [1] 306115 0
Approval date [1] 306115 0
15/05/2020
Ethics approval number [1] 306115 0
LRR 070/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102762 0
Dr Nathan Kerr
Address 102762 0
Centre for Eye Research Australia
Level 7, 32 Gisborne Street
East Melbourne VIC 3002
Australia

International Glaucoma Surgery Registry
145 City Rd
London EC1V 1AW
United Kingdom
Country 102762 0
Australia
Phone 102762 0
+61 3 9929 8360
Fax 102762 0
Email 102762 0
nathan.kerr@eyeandear.org.au
Contact person for public queries
Name 102763 0
Nathan Kerr
Address 102763 0
Centre for Eye Research Australia
Level 7, 32 Gisborne Street
East Melbourne VIC 3002
Australia

International Glaucoma Surgery Registry
145 City Rd
London EC1V 1AW
United Kingdom
Country 102763 0
Australia
Phone 102763 0
+61 3 9929 8360
Fax 102763 0
Email 102763 0
nathan.kerr@eyeandear.org.au
Contact person for scientific queries
Name 102764 0
Nathan Kerr
Address 102764 0
Centre for Eye Research Australia
Level 7, 32 Gisborne Street
East Melbourne VIC 3002
Australia

International Glaucoma Surgery Registry
145 City Rd
London EC1V 1AW
United Kingdom
Country 102764 0
Australia
Phone 102764 0
+61 3 9929 8360
Fax 102764 0
Email 102764 0
nathan.kerr@eyeandear.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbasePrimary Needling of the Ab Interno Gelatin Microstent Reduces Postoperative Needling and Follow-up Requirements.2021https://dx.doi.org/10.1016/j.ogla.2021.02.004
N.B. These documents automatically identified may not have been verified by the study sponsor.