GlaucomaPhase 1NCT00551902
Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
A Phase 1 study testing Trabeculectomy with anterior chamber infusion system and Trabeculectomy without anterior chamber infusion system in people with Glaucoma, run by Queen's University at 2 sites in Canada.
Trial summary
In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Trabeculectomy with anterior chamber infusion system and Trabeculectomy without anterior chamber infusion system
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2007to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- One of the following diagnoses:
- primary open angle glaucoma
- chronic angle closure glaucoma
- pseudo exfoliation glaucoma
- pigment dispersion glaucoma
Who cannot join
- unable to provide consent or return for follow up
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hotel Dieu Hospital, Queen's University
Kingston, Ontario, K7L 5G2
Toronto Western Hospital, University of Toronto
Toronto, Ontario
About this study
In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.
Read the detailed description
The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.
Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.
- Conditions
- Glaucoma
- Being tested
- Trabeculectomy with anterior chamber infusion system, Trabeculectomy without anterior chamber infusion system
- Keywords
- Glaucoma, trabeculectomy, anterior chamber maintainer, anterior chamber infusion
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabeculectomy with anterior chamber infusion systemProcedure or surgery
Trabeculectomy with anterior chamber infusion system
Trabeculectomy without anterior chamber infusion systemProcedure or surgery
Standard trabeculectomy surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Trabeculectomy with anterior chamber infusion system Receives: Procedure: Trabeculectomy with anterior chamber infusion system |
| 2 | Active comparator | Trabeculectomy without anterior chamber infusion system Receives: Procedure: Trabeculectomy without anterior chamber infusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical success: intraocular pressure lowered by 30% and functional filtering bleb
Measured: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery
Secondary outcomes (2)
Need for laser suture lysis
Measured: any point post operatively
complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing
Measured: any time post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Efficacy study indicated that further study is not warranted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Glaucoma Research & Education Group
- Responsible party
- Principal investigator, Dr. Robert Campbell, Queen's University
- Investigators
- Robert J Campbell, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551902
- Sponsor's protocol ID
- RC-2
- Status last verified
- Sep 2015
- First submitted
- 29 Oct 2007
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
- ClinicalTrials.gov ID
- NCT00551902
- Acronym / sponsor ID
- RC-2
- Conditions
- Glaucoma
- Keywords
- Glaucoma, trabeculectomy, anterior chamber maintainer, anterior chamber infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Efficacy study indicated that further study is not warranted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Glaucoma Research & Education Group
- Study start
- Sep 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.
Detailed description
The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.
Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Trabeculectomy with anterior chamber infusion systemTrabeculectomy with anterior chamber infusion system |
| 2 | Active comparator | Procedure: Trabeculectomy without anterior chamber infusion systemTrabeculectomy without anterior chamber infusion system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age
- One of the following diagnoses:
Key exclusion criteria (1 listed)
- unable to provide consent or return for follow up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabeculectomy with anterior chamber infusion systemTrabeculectomy with anterior chamber infusion system | Procedure or surgery | 1 |
| Trabeculectomy without anterior chamber infusion systemStandard trabeculectomy surgery | Procedure or surgery | 2 |
Primary outcome
surgical success: intraocular pressure lowered by 30% and functional filtering bleb
Time frame: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery
2 secondary outcomes
Need for laser suture lysis
Time frame: any point post operatively
complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing
Time frame: any time post operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert J Campbell, MD principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trabeculectomy with anterior chamber infusion system and Trabeculectomy without anterior chamber infusion system in people with Glaucoma, run by Queen's University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical success: intraocular pressure lowered by 30% and functional filtering bleb (time frame: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.