GlaucomaPhase 4NCT00273221
Combined Phacotube vs Phacotrabeculectomy:A Randomized Controlled Trial
A Phase 4 study testing Glaucoma Implant Surgery, trabeculectomy and phacoemulsification in people with Glaucoma and Cataract, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The aim of this study is to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) with phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control… Read more about this study
- Who is it for?
- Ages 21 years and older
- What is being tested?
- Glaucoma Implant Surgery, trabeculectomy and phacoemulsification
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2005to Jul 2006
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ø 21 years old and above Ø Primary Open Angle Glaucoma with Shaffer grade 2 or better for 360 degrees Ø Primary Angle Closure Glaucoma (occludable angles +/- PAS) Ø Inadequate IOP control despite maximum medical treatment (using at least 2 types or more antiglaucoma medications) and/or laser treatment in the presence of glaucomatous optic neuropathy on optic nerve head evaluation and corresponding visual field findings Ø Visually significant cataract with visual acuity of less than or equal to 6/12 Ø No corneal disease Ø Willing to be followed up for 1 year duration post-operatively Ø Informed consent
Who cannot join
- Ø Secondary Glaucoma (Uveitic, Neovascular, traumatic, Iridocorneal Endothelial Syndrome); Congenital Glaucoma Ø Severe ocular disease like Proliferative Diabetic Retinopathy, Age-related Macular Degeneration Exudative type Ø Prior intraocular surgery(in the study eye) Ø Patients with small central island and temporal field remaining on perimetry Ø One-eyed patients or fellow eye with visual acuity of counting fingers (CF) or worse
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
5 Lower Kent Ridge Road, 119074
Paul TC Chew, A/Professor, 67725317 ext. 5317, ophchew@nus.edu.sg
Maria Cecilia D Aquino, MD, 67725317 ext. 5317, cel_aq@yahoo.com
About this study
Official title: Combined Phacoemulsification and Glaucoma Implant Surgery Versus Combined Phacoemulsification and Trabeculectomy: A Randomized Controlled Trial
The aim of this study is to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) with phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP) in patients with primary open angle and angle closure glaucoma.
Read the detailed description
Studies have pointed out racial differences in the outcome of conventional filtration surgery. Glaucoma drainage implants have been found to do well in Asian eyes but no randomized controlled trial is available to support this claim. Objectives: It is the aim of this study to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) versus phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP) in patients with primary open angle and angle closure glaucoma. The secondary objective is to look into the post-operative complications encountered in phacotrabeculectomy and phacotube including the additional interventions (laser suture lysis, bleb needling, antimetabolite injections, etc.) applied in both procedures being studied Study Design. Randomized controlled trial. Methods. A total of 50 Asian subjects, 21 years old and above diagnosed with primary open/angle closure glaucoma, inadequately controlled by laser and medical treatment, with significant cataract and no previous eye surgery will be randomized to two types of combined procedures, phacotrabeculectomy and phacotube. Primary outcome measure is intraocular pressure and secondary outcome measures will be visual acuity, anterior chamber depth, visual field stability or progression, glaucoma medication requirement, operative and post-operative complications and additional, secondary interventions(e.g. laser suture lysis, bleb needling, 5-FU injections, anterior chamber reformation). All subjects will be followed up for a period of 1 year.This trial may define the role of GDI as a primary surgical option for Asian patients and the first randomized clinical trial in Asia to compare two combined procedures for glaucoma and cataract namely phacotrabeculectomy and phaco-glaucoma drainage implant surgery.
- Being tested
- Glaucoma Implant Surgery, trabeculectomy, phacoemulsification
- Keywords
- Glaucoma, Cataract
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma Implant SurgeryProcedure or surgery
trabeculectomyProcedure or surgery
phacoemulsificationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure(IOP).
Secondary outcomes (1)
visual acuity,anterior chamber depth,visual field, glaucoma medication requirement, operative and post-operative complications and additional interventions(e.g.laser suture lysis, bleb
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJul 2005
- Study completionJul 2006 (estimated)
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.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Paul TC Chew, A/Prof, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273221
- Sponsor's protocol ID
- DSRB-A/05/196
- Status last verified
- May 2008
- First submitted
- 6 Jan 2006
- Last updated
- 22 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phacoemulsification and Glaucoma Implant Surgery Versus Combined Phacoemulsification and Trabeculectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00273221
- Acronym / sponsor ID
- DSRB-A/05/196
- Keywords
- Glaucoma, Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jul 2006 (estimated)
- First posted
- 9 Jan 2006 (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.
The aim of this study is to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) with phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP) in patients with primary open angle and angle closure glaucoma.
Detailed description
Studies have pointed out racial differences in the outcome of conventional filtration surgery. Glaucoma drainage implants have been found to do well in Asian eyes but no randomized controlled trial is available to support this claim. Objectives: It is the aim of this study to compare the effectiveness and safety of combined phacoemulsification, posterior chamber intraocular lens implantation , trabeculectomy (phacotrabeculectomy) versus phacoemulsification, intraocular lens implantation and glaucoma drainage device(phacotube) in the early and intermediate control of intraocular pressure(IOP) in patients with primary open angle and angle closure glaucoma. The secondary objective is to look into the post-operative complications encountered in phacotrabeculectomy and phacotube including the additional interventions (laser suture lysis, bleb needling, antimetabolite injections, etc.) applied in both procedures being studied Study Design. Randomized controlled trial. Methods. A total of 50 Asian subjects, 21 years old and above diagnosed with primary open/angle closure glaucoma, inadequately controlled by laser and medical treatment, with significant cataract and no previous eye surgery will be randomized to two types of combined procedures, phacotrabeculectomy and phacotube. Primary outcome measure is intraocular pressure and secondary outcome measures will be visual acuity, anterior chamber depth, visual field stability or progression, glaucoma medication requirement, operative and post-operative complications and additional, secondary interventions(e.g. laser suture lysis, bleb needling, 5-FU injections, anterior chamber reformation). All subjects will be followed up for a period of 1 year.This trial may define the role of GDI as a primary surgical option for Asian patients and the first randomized clinical trial in Asia to compare two combined procedures for glaucoma and cataract namely phacotrabeculectomy and phaco-glaucoma drainage implant surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ø 21 years old and above Ø Primary Open Angle Glaucoma with Shaffer grade 2 or better for 360 degrees Ø Primary Angle Closure Glaucoma (occludable angles +/- PAS) Ø Inadequate IOP control despite maximum medical treatment (using at least 2 types or more antiglaucoma medications) and/or laser treatment in the presence of glaucomatous optic neuropathy on optic nerve head evaluation and corresponding visual field findings Ø Visually significant cataract with visual acuity of less than or equal to 6/12 Ø No corneal disease Ø Willing to be followed up for 1 year duration post-operatively Ø Informed consent
Key exclusion criteria (1 listed)
- Ø Secondary Glaucoma (Uveitic, Neovascular, traumatic, Iridocorneal Endothelial Syndrome); Congenital Glaucoma Ø Severe ocular disease like Proliferative Diabetic Retinopathy, Age-related Macular Degeneration Exudative type Ø Prior intraocular surgery(in the study eye) Ø Patients with small central island and temporal field remaining on perimetry Ø One-eyed patients or fellow eye with visual acuity of counting fingers (CF) or worse
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 |
|---|---|---|
| Glaucoma Implant Surgery | Procedure or surgery | – |
| trabeculectomy | Procedure or surgery | – |
| phacoemulsification | Procedure or surgery | – |
Primary outcome
intraocular pressure(IOP).
1 secondary outcome
visual acuity,anterior chamber depth,visual field, glaucoma medication requirement, operative and post-operative complications and additional interventions(e.g.laser suture lysis, bleb
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2008.
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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.
Paul TC Chew, A/Prof principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glaucoma Implant Surgery, trabeculectomy and phacoemulsification in people with Glaucoma and Cataract, run by National University Hospital, Singapore at 1 site in Singapore.
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 1 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: status not confirmed, as of the sponsor's last update on 22 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul TC Chew, A/Prof. (67725317 ext. 5317, ophchew@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure(IOP).. 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 22 May 2008.