Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000825257
Ethics application status
Approved
Date submitted
29/12/2017
Date registered
15/05/2018
Date last updated
15/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effectiveness of Paul Glaucoma Implant (PGI) – a pilot study
Scientific title
An investigation of the effectiveness of Paul Glaucoma Implant (PGI) – a pilot study
Secondary ID [1] 293696 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 306030 0
Condition category
Condition code
Eye 305177 305177 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Under general anesthesia, peritomy and blunt dissection are done. The Paul Glaucoma Implant (PGI) is checked for patency and a rectangular pericardial patch graft (Tutopatch®) is placed on top of the plate posterior to the valve before the plate is sutured in place 8.5-10mm away from the limbus using Nylon 8/0. Anterior chamber paracentesis is done.
If it is a combined cataract and glaucoma surgery, the surgeon proceeds with phacoemulsification with intraocular lens implant.
The pupil is then miosed and the anterior chamber is reformed with viscoelastic. The tube is then cut to desired length and the track for the tube towards the anterior chamber is created. The tube is then fixed in place with interrupted sutures and covered with Tutopatch® using a fibrin sealant (Tisseel VH S/D, Baxter Healthcare Pte Ltd). Approximately 0.3mL of cross-linked viscoelastic is then injected around & above the plate before closing the conjunctiva. Subconjunctival injection of Gentamycin 20mg with Dexamethasone 4mg is then given at the end of the procedure.

The approximate time commitment of the intervention will be around 3 to 4 hours. The intervention will be administered by surgeons
Intervention code [1] 299951 0
Treatment: Surgery
Comparator / control treatment
The use of existing/conventional glaucoma drainage implants or performing other glaucoma filtering surgery (e.g. trabeculectomy, a procedure that shunts aqueous from inside the eye to underneath the conjunctiva without the use of implant ) or laser surgery (e.g. diode cyclophotocoagulation).

This a concurrent control group
Control group
Active

Outcomes
Primary outcome [1] 304335 0
Intraocular pressure (IOP) assessed using Goldmann Applanation Tonometry
Timepoint [1] 304335 0
One year post-enrolment
Secondary outcome [1] 341615 0
To investigate the indications for use in the target population, use of Refraction, Visual Acuity, Slit Lamp examination , Indentation gonioscopy, Indentation gonioscopy, Pachymetry, Specular microscopy and Ocular motility Evaluation to access
Timepoint [1] 341615 0
One year post-enrolment

Eligibility
Key inclusion criteria
• Age between 21 - 80 years old
• Eyes with severe, refractory glaucoma defined as IOP exceeding 21 mmHg on maximal tolerated medical therapy with any of the following: i) failed 1 or more incisional glaucoma surgeries (glaucoma filtering surgery, trabeculectomy, tube shunt); ii) failed 1
or more cilioablative procedures(e.g. cryotherapy, cyclodiode therapy); iii) have any other conditions (conjunctival scarring uveitis) in which conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail)
• Eyes with moderate glaucoma defined as eyes with glaucomatous visual field defects not affecting the central 5 degrees of fixation, requires more than 1 IOP-lowering eyedrops and has visually-significant cataract requiring cataract surgery
• Maximally-tolerated medicated IOP at two preoperative visits of greater 21 mmHg and greater than or equal to 35 mmHg
• Area of free, healthy and mobile conjunctiva in the targeted quadrant
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unwilling or unable to give consent, or unable to return for scheduled visits.
• Fellow eye VA worse than 6/60.
• other significant ocular disease, except cataract
• active ocular infection or inflammation
• expected ocular surgery in next 12 months
• no suitable quadrant for tube implant
• systemic corticosteroid therapy > 5 mg/day prednisone
• intolerance to eye exams
• mental impairment interfering with consent or compliance
• pregnant or nursing women
• known sensitivity to anticipated medications used at surgery
• significant co-morbid disease
• concurrent enrolment in another drug or device study

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)
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Since this is a pilot series, non-comparative trial, statistical calculation would not be used for determining the number of subjects
to be recruited for the study. This is a prospective case series with a small sample size. The outcome of the study subjects would
be reported individually.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
26/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 9468 0
Hong Kong
State/province [1] 9468 0

Funding & Sponsors
Funding source category [1] 298314 0
University
Name [1] 298314 0
National University Hospital (S) Pte Ltd
Country [1] 298314 0
Singapore
Primary sponsor type
University
Name
National University Hospital (S) Pte Ltd
Address
National University Hospital (S) Pte Ltd
5 Lower Kent Ridge Road
Singapore 119074
Country
Singapore
Secondary sponsor category [1] 297427 0
None
Name [1] 297427 0
Address [1] 297427 0
Country [1] 297427 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299309 0
Kowloon Central Kowloon East Cluster
Ethics committee address [1] 299309 0
Block S, Queen Elizabeth Hospital
30 Gascoigne Road
KOWLOON
Ethics committee country [1] 299309 0
Hong Kong
Date submitted for ethics approval [1] 299309 0
13/06/2017
Approval date [1] 299309 0
23/11/2017
Ethics approval number [1] 299309 0
KC/KE-17-0107-FR-4 (1)

Summary
Brief summary
The study objective is to determine the safety and efficacy of a new shunt that has been developed to eliminate some of the disadvantages of current shunts in the treatment of refractory/severe and moderate glaucoma in severity. It is hypothesized that this new device will lower intraocular pressure with nil to diminished frequency of commonly encountered problems with the present day aqueous shunts.

Treatment of glaucoma aims at lowering the eye pressure by medication, laser or surgical procedure. The traditional first line surgery is trabeculectomy, which involves creating a new drainage hole that would result in the formation of a bleb. This would achieve
lowering of the eye pressure. If trabeculectomy fails, then the implantation of glaucoma drainage device (GDD) would be considered. Existing GDDs include Baerveldt, Molteno, Ahmed and Krupin. Although aqueous shunts have traditionally been used as the last
treatment resort, a recent study with 5 years data has been published and demonstrated that the performance of shunts is comparable to that of trabeculectomy.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2306 2306 0 0
/AnzctrAttachments/374236-19.07.2017_PGI_Case_series_protocol v3_20171024_clean.pdf (Protocol)
Attachments [2] 2307 2307 0 0
/AnzctrAttachments/374236-17-0107-FR-4 (1) Prof THAM Chee Yung Clement 23Nov2017.pdf (Ethics approval)
Attachments [3] 2308 2308 0 0
/AnzctrAttachments/374236-3. Informed Consent Form 171108_clean.pdf (Participant information/consent)

Contacts
Principal investigator
Name 80002 0
Prof Tham Chee Yung Clement
Address 80002 0
Department of Ophthalmology & Visual Sciences,
3/F, Hong Kong Eye Hospital
147K Argyle Street
KOWLOON
Country 80002 0
Hong Kong
Phone 80002 0
+852-39435825
Fax 80002 0
Email 80002 0
clemtham@cuhk.edu.hk
Contact person for public queries
Name 80003 0
Ms Janice Wong
Address 80003 0
Department of Ophthalmology & Visual Sciences,
3/F, Hong Kong Eye Hospital
147K Argyle Street
KOWLOON
Country 80003 0
Hong Kong
Phone 80003 0
+85239435825
Fax 80003 0
Email 80003 0
janicewong@cuhk.edu.hk
Contact person for scientific queries
Name 80004 0
Dr Chan Pui Man Poemen
Address 80004 0
Department of Ophthalmology & Visual Sciences,
3/F, Hong Kong Eye Hospital
147K Argyle Street
KOWLOON
Country 80004 0
Hong Kong
Phone 80004 0
+85239435825
Fax 80004 0
Email 80004 0
poemen@gmail.com

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
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