Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001102763
Ethics application status
Not yet submitted
Date submitted
1/10/2013
Date registered
2/10/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
STARflo Glaucoma Implant for Open Angle Glaucoma
Scientific title
A Prospective Single Centre Phase 4 Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients with Open Angle Glaucoma
Secondary ID [1] 283335 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open-Angle Glaucoma 290227 0
Condition category
Condition code
Eye 290621 290621 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implantation of STARflo glaucoma implant into the anterior chamber and suprachoroidal space. The STARflo glaucoma implant (v2.0) is a 5mm x 8mm silicone device made using a patented porous biomatrix designed to facilitate the flow of aqueous fluid through it and enhance compatibility with surrounding tissues. Implantation is performed via an external approach under local anaesthesia and is anticipated to take 45 - 60 minutes.
Intervention code [1] 288057 0
Treatment: Surgery
Intervention code [2] 288062 0
Treatment: Devices
Comparator / control treatment
Glaucoma control prior to surgery
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290632 0
Intraocular Pressure using Goldmann applanation tonometry
Timepoint [1] 290632 0
12 months
Secondary outcome [1] 304936 0
Visual Acuity using snellen acuity charts
Timepoint [1] 304936 0
12 months
Secondary outcome [2] 304937 0
Visual Field using automated perimetry
Timepoint [2] 304937 0
12 months
Secondary outcome [3] 304938 0
Number of glaucoma medications (patient self report and documented by treating doctor)
Timepoint [3] 304938 0
12 months
Secondary outcome [4] 304939 0
Quality of Life (GQL-15 Quality of Life Questionnaire)
Timepoint [4] 304939 0
12 months

Eligibility
Key inclusion criteria
1. Males or females 18 years of age or greater.
2. Diagnosis of open angle glaucoma in the study eye.
3. Concurrent treatment with ocular hypotensive medications in the study eye and/or oral acetazolamide.
4. Documented IOP > or = 21 mmHg in the study eye on medical therapy at two visits at least 48 hours apart, within six weeks prior to study entry and at day 0.
5. Glaucoma progression despite current medical and/or laser trabeculoplasty treatment OR intolerance of current medical and/or laser trabeculoplasty treatment OR inadequate IOP reduction with medical and/or laser trabeculoplasty treatment.
6. Patient willing and able to undergo implantation of the STARflo in the study eye and return for scheduled study-related examinations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of secondary open angle glaucoma where STARflo implant is considered contraindicated (e.g., traumatic, uveitic, or neovascular glaucoma).
2. Diagnosis of angle-closure glaucoma or angle-closure suspect
Clinically significant corneal disease (e.g., corneal dystrophy, corneal graft)
3. Any previous ophthalmic surgery in the same eye quadrant other than trabeculectomy, trabeculoplasty, and cataract surgery within 3 months prior to study entry.
4. Laser trabeculoplasty within three months prior to study.
Active vascular or inflammatory retinopathy (diabetes, hypertension, uveitis)
5. Intra-ocular inflammation or infection within six months prior to study
6. Evidence of crystalline lens subluxation or luxation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients identified by participating specialists deemed to require surgery for glaucoma management and meeting inclusion/exclusion criteria will be offered participation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1571 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment postcode(s) [1] 7405 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 288068 0
Self funded/Unfunded
Name [1] 288068 0
Country [1] 288068 0
Primary sponsor type
Hospital
Name
South East Sydney Illawarra Area Health Service
Address
Edmund Blacket Building
Prince of Wales Hospital
Cnr High Street and Avoca Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 286789 0
None
Name [1] 286789 0
Address [1] 286789 0
Country [1] 286789 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289994 0
SESLHD Human Research Ethics Committee
Ethics committee address [1] 289994 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Cnr High Street and Avoca Street
Randwick NSW 2031
Ethics committee country [1] 289994 0
Australia
Date submitted for ethics approval [1] 289994 0
08/10/2013
Approval date [1] 289994 0
Ethics approval number [1] 289994 0
13/253

Summary
Brief summary
Assess the intraocular pressure (IOP) reduction induced by the STARflo glaucoma implant in eyes with open angle glaucoma. Absolute success is defined as an IOP < 21mmHg and > 5mmHg with a minimum 20% IOP reduction from baseline without the need for glaucoma medication. Qualified success is defined as an IOP < 21mmHg and > 5mmHg with a minimum 20% IOP reduction from baseline with the concomitant use of glaucoma medication.


This is a prospective, single centre study of the CE marked and TGA approved STARflo glaucoma implant. Patients with open angle glaucoma requiring surgical reduction of IOP will be screened for suitability for inclusion in the study. Following implantation of the STARflo, participants will be followed for a minimum 12-months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43398 0
Dr Colin Clement
Address 43398 0
Glaucoma Unit
Sydney Eye Hospital
8 Macquarie Street
Sydney NSW 2000
Country 43398 0
Australia
Phone 43398 0
+612 9382 7111
Fax 43398 0
Email 43398 0
[email protected]
Contact person for public queries
Name 43399 0
Dr Colin Clement
Address 43399 0
Glaucoma Unit
Sydney Eye Hospital
8 Macquarie Street
Sydney NSW 2000
Country 43399 0
Australia
Phone 43399 0
+612 9382 7111
Fax 43399 0
Email 43399 0
[email protected]
Contact person for scientific queries
Name 43400 0
Dr Colin Clement
Address 43400 0
Glaucoma Unit
Sydney Eye Hospital
8 Macquarie Street
Sydney NSW 2000
Country 43400 0
Australia
Phone 43400 0
+612 9382 7111
Fax 43400 0
Email 43400 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.