GlaucomaPhase 3NCT01027247
OculusGen™ Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: a Case-Control Study
A Phase 3 study testing Ologen TM in people with Glaucoma, run by Singapore National Eye Centre.
Trial summary
Frequently glaucoma is not controlled with clinical treatment ("eyedrops") or laser surgery to control your eye pressure. If this raised pressure is sustained over a long period of time it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can result in blindness. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ologen TM
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with primary glaucoma.
- Age 21 years or over.
- Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- Visually impairing cataract, requiring cataract extraction surgery.
- Subject able and willing to cooperate with investigation plan.
- Subject able and willing to complete postoperative follow-up requirements.
- Subject willing to sign informed consent form.
Who cannot join
- Known allergic reaction to porcine collagen.
- Vertical cup-disc ratio ≥ 0.9.
- Patients with secondary glaucoma.
- Previous intraocular surgery
- Subject is on warfarin and discontinuation is not recommended.
- Participation in an investigational study during the 30 days preceding trabeculectomy.
Show all 9Show fewer
- Ocular infection within 14 days prior to trabeculectomy.
- Pregnant or breast-feeding women
- -
About this study
Frequently glaucoma is not controlled with clinical treatment ("eyedrops") or laser surgery to control your eye pressure. If this raised pressure is sustained over a long period of time it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can result in blindness. You also have cataracts, an opacification of the natural lens inside the eye that is impairing your vision. To prevent further vision loss due to glaucoma, your doctor has recommended glaucoma filtration surgery to lower your eye pressure, and cataract surgery at the same time to improve your sight.
The use of the anti-metabolite (Mitomycin-C) during the operation is currently the drug of choice to improve surgical outcome for glaucoma filtration surgery. Mitomycin-C is a potent antiscarring agent that reduces the amount of scar tissue produced after surgery which leads to better control of eye pressure. Although this potent drug is effective in increasing surgical success, its use is related to a higher risk of post surgical complications, some of which are sight threatening.
Read more
The Collagen Matrix Implant is a biodegradable implant (absorbed naturally by tissue), made from porcine collagen, which reduces scar tissue formed after glaucoma filtration surgery without the use of Mitomycin-C. This means that you could be less likely to have a failed glaucoma filtration surgery, and consequently, a poor eye pressure control. In addition, the risk of surgical failure may be reduced because with this technique, we will not be using potent drugs. However, the long-term effect of the OculusGenTm implant in glaucoma filtration surgery is not fully known.
The aim of the study is to determine whether the OculusGenTm implant can equal the success rate of Mitomycin-C in controlling eye pressure, without the potentially sight threatening complications associated with Mitomycin use. And at the same time, this study aim to determine if the implant can reduce potential complications related to glaucoma surgery when compared to the combined surgery augmented with anti-proliferative agents.
This study will recruit 66 subjects from patients attending the Singapore National Eye Centre over a period of 12-24 months.
- Conditions
- Glaucoma
- Being tested
- Ologen TM
- Keywords
- Primary Glaucoma
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ologen TMDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in Phaco-Trabeculectomy surgeries in patients with Primary Glaucoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (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.
- 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 3
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027247
- Sponsor's protocol ID
- R539/27/2007
- Status last verified
- Dec 2009
- First submitted
- 4 Dec 2009
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OculusGen™ Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: a Case-Control Study
- ClinicalTrials.gov ID
- NCT01027247
- Acronym / sponsor ID
- R539/27/2007
- Conditions
- Glaucoma
- Keywords
- Primary Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Singapore National Eye CentreOther government
- First posted
- 7 Dec 2009 (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.
Frequently glaucoma is not controlled with clinical treatment ("eyedrops") or laser surgery to control your eye pressure. If this raised pressure is sustained over a long period of time it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can result in blindness. You also have cataracts, an opacification of the natural lens inside the eye that is impairing your vision. To prevent further vision loss due to glaucoma, your doctor has recommended glaucoma filtration surgery to lower your eye pressure, and cataract surgery at the same time to improve your sight.
The use of the anti-metabolite (Mitomycin-C) during the operation is currently the drug of choice to improve surgical outcome for glaucoma filtration surgery. Mitomycin-C is a potent antiscarring agent that reduces the amount of scar tissue produced after surgery which leads to better control of eye pressure. Although this potent drug is effective in increasing surgical success, its use is related to a higher risk of post surgical complications, some of which are sight threatening.
The Collagen Matrix Implant is a biodegradable implant (absorbed naturally by tissue), made from porcine collagen, which reduces scar tissue formed after glaucoma filtration surgery without the use of Mitomycin-C. This means that you could be less likely to have a failed glaucoma filtration surgery, and consequently, a poor eye pressure control. In addition, the risk of surgical failure may be reduced because with this technique, we will not be using potent drugs. However, the long-term effect of the OculusGenTm implant in glaucoma filtration surgery is not fully known.
The aim of the study is to determine whether the OculusGenTm implant can equal the success rate of Mitomycin-C in controlling eye pressure, without the potentially sight threatening complications associated with Mitomycin use. And at the same time, this study aim to determine if the implant can reduce potential complications related to glaucoma surgery when compared to the combined surgery augmented with anti-proliferative agents.
This study will recruit 66 subjects from patients attending the Singapore National Eye Centre over a period of 12-24 months.
Study design
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with primary glaucoma.
- Age 21 years or over.
- Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy.
- Visually impairing cataract, requiring cataract extraction surgery.
- Subject able and willing to cooperate with investigation plan.
Key exclusion criteria (9 listed)
- Known allergic reaction to porcine collagen.
- Vertical cup-disc ratio ≥ 0.9.
- Patients with secondary glaucoma.
- Previous intraocular surgery
- Subject is on warfarin and discontinuation is not recommended.
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 |
|---|---|---|
| Ologen TM | Device | – |
Primary outcome
To assess the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in Phaco-Trabeculectomy surgeries in patients with Primary Glaucoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ologen TM in people with Glaucoma, run by Singapore National Eye Centre.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 7 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in Phaco-Trabeculectomy surgeries in patients with Primary Glaucoma. 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 7 Dec 2009.