Advanced GlaucomaPhase 2NCT00453024
Imaging Ahmed Glaucoma Tubes With a Pericardial Graft and Tissue Glue or Partial-Thickness Scleral Flap and Sutures
A Phase 2 study testing Pericardial graft & tissue glue and scleral flap & sutures in people with Advanced Glaucoma and Failed Trabeculectomies, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
When implanting an Ahmed glaucoma tube, a scleral flap is usually created to cover the tube, and the conjunctiva is stitched back in place with nylon 10-0 sutures. It is hypothesized that an equally safe or better method is using a bovine pericardial patch graft that can be secured in place over the tube with tissue… Read more about this study
- Who is it for?
- Ages 41 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Glaucoma, Failed Trabeculectomies
- What is being tested?
- Pericardial graft & tissue glue and scleral flap & sutures
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2007to Mar 2008
- Phase
- Phase 2
- 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 41 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- More than 40 years old
- Able to give informed consent
- Diagnosis of any type of glaucoma needing a Glaucoma drainage device (Ahmed tube implant) with or without lens extraction and intraocular lens implant because of uncontrolled intraocular pressures inspite of maximum tolerated medical therapy
Who cannot join
- Inability to give informed consent
- History of ocular infection or inflammation in the past two months
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Jovina See, MMed,FRCS
Cecilia Aquino, MD
About this study
Official title: Anterior Segment Optical Coherence Tomography Findings in Patients With Ahmed Glaucoma Drainage Implants With Either a Pericardial Patch Graft and Fibrin Tissue Glue or a Partial-Thickness Scleral Flap and Conventional Sutures
When implanting an Ahmed glaucoma tube, a scleral flap is usually created to cover the tube, and the conjunctiva is stitched back in place with nylon 10-0 sutures. It is hypothesized that an equally safe or better method is using a bovine pericardial patch graft that can be secured in place over the tube with tissue glue, and using tissue glue to reposition the conjunctiva in place.
Read the detailed description
Glaucoma drainage devices (GDD) are usually reserved for cases wherein filtration surgery has failed, or for difficult cases that do not respond to filtration surgery, such as neovascular or uveitic glaucoma.
The Ahmed Glaucoma drainage implant (New World Medical, Rancho, Cucamonga,CA) was introduced to the market in 19942. It has a scarab-shaped end plate made of polypropylene (models S2, S3 and B1) or silicone models (FP7, FP8 and FX1). Fenestrations have been added to the end plate of the silicone models. Various sizes of the Ahmed drainage are available, including those with a surface area of 96 mm2 (S3 and FP8) or 184 mm2 (S2 and FP7); while the double-plate version has a surface area of 364mm2 (B1 and FX1). Aqueous humor passes from the anterior chamber through two thin membrane-like elastomer sheets that theoretically restrict flow until a pressure of greater than 8-12 mm Hg is exerted on them.
In the implantation of GDD, absorbable and non-absorbable sutures are used. Sutures are typically used in securing the plate to the sclera, securing the tube to the sclera, suturing a patch graft or scleral flap over the silicone tube, and for conjunctival closure. Post-surgical course can be marked by discomfort, depending on the type of suture used. Absorbable sutures can induce inflammation with localized surface and subconjunctival fibrosis that leads to uneven conjunctival surface and excessive scarring. On the other hand, non-absorbable sutures can erode through tissue post-operatively. Suturing the conjunctiva can cause button-holes and tears, and can be the most time-intensive portion of the surgery.
Fibrin glue has been used in various ophthalmic surgeries such as a sealant for perforated and preperforated corneal ulcers, in mucous membrane grafts, in the management of complicated hypotony and bleb leaks after trabeculectomy, and for preventing immediate postoperative hypotony after glaucoma drainage implant surgery.
In a paper by Kahook and Noecker published in 2006, the authors did a retrospective non-randomized case-control study that reviewed 28 cases of GDD implantations using traditional suture materials compared to 14 consecutive cases of GDD implantation using Tisseel fibrin glue (Baxter AG, Vienna, Austria) for closing the conjunctiva, securing the pericardium patch graft and securing the tube to the sclera. The authors concluded that Tisseel fibrin glue seems to be a safe substitute for some of the sutures used in GDD surgery; and it has no impact on IOP control or complications. It appears to reduce post-operative conjunctival inflammation and time of surgery.
Optical coherence tomography (OCT) is a high-resolution, non-invasive and reproducible imaging technology that was primarily developed to evaluate the retina and retina nerve fiber layer in patients with vitreo-retinal or optic nerve diseases11. Recently, the anterior segment OCT (AS-OCT) has been developed and used to image anterior segment structures. It has also been used to localize the Ex-PRESS miniature glaucoma implant in porcine eyes, while the conventional OCT was used to show the anterior segment findings after non-penetrating deep sclerectomy and the filtering blebs of eyes that underwent glaucoma filtering surgery.
Patients scheduled for Ahmed Tube surgery, with or without lens extraction and intraocular lens implant, will be recruited and randomized into two groups. The first group of patients will have a pericardial patch graft covering the tube, and fibrin glue will be used to attach the graft to the sclera and to close the conjunctiva. The second group will have a partial- thickness scleral flap raised to cover the tube, and the conjunctiva will be closed with conventional sutures.
- Conditions
- Advanced Glaucoma, Failed Trabeculectomies
- Being tested
- Pericardial graft & tissue glue, scleral flap & sutures
- Keywords
- Advanced glaucoma, Ahmed glaucoma implant, Anterior segment optical coherence tomography, Pericardial patch graft, Tissue glue, Scleral flap, Sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericardial graft & tissue glueProcedure or surgery
scleral flap & suturesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior segment optical coherence tomography appearance and measurements of the overlying conjunctiva, areas above and beneath the pericardial patch graft or partial thickness scleral flap, anterior chamber depth
Intraocular pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startFeb 2007
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Advanced 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Paul Chew, FRCSEd,MMed, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453024
- Sponsor's protocol ID
- DSRB A/06/375
- Status last verified
- May 2008
- First submitted
- 27 Mar 2007
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Savini G, Zanini M, Barboni P. Filtering blebs imaging by optical coherence tomography. Clin Exp Ophthalmol. 2005 Oct;33(5):483-9. doi: 10.1111/j.1442-9071.2005.01066.x.
PubMed 16181273Kahook MY, Noecker RJ. Fibrin glue-assisted glaucoma drainage device surgery. Br J Ophthalmol. 2006 Dec;90(12):1486-9. doi: 10.1136/bjo.2006.101253. Epub 2006 Aug 17.
PubMed 16916877
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Optical Coherence Tomography Findings in Patients With Ahmed Glaucoma Drainage Implants With Either a Pericardial Patch Graft and Fibrin Tissue Glue or a Partial-Thickness Scleral Flap and Conventional Sutures
- ClinicalTrials.gov ID
- NCT00453024
- Acronym / sponsor ID
- DSRB A/06/375
- Conditions
- Advanced Glaucoma, Failed Trabeculectomies
- Keywords
- Advanced glaucoma, Ahmed glaucoma implant, Anterior segment optical coherence tomography, Pericardial patch graft, Tissue glue, Scleral flap, Sutures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 28 Mar 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.
When implanting an Ahmed glaucoma tube, a scleral flap is usually created to cover the tube, and the conjunctiva is stitched back in place with nylon 10-0 sutures. It is hypothesized that an equally safe or better method is using a bovine pericardial patch graft that can be secured in place over the tube with tissue glue, and using tissue glue to reposition the conjunctiva in place.
Detailed description
Glaucoma drainage devices (GDD) are usually reserved for cases wherein filtration surgery has failed, or for difficult cases that do not respond to filtration surgery, such as neovascular or uveitic glaucoma.
The Ahmed Glaucoma drainage implant (New World Medical, Rancho, Cucamonga,CA) was introduced to the market in 19942. It has a scarab-shaped end plate made of polypropylene (models S2, S3 and B1) or silicone models (FP7, FP8 and FX1). Fenestrations have been added to the end plate of the silicone models. Various sizes of the Ahmed drainage are available, including those with a surface area of 96 mm2 (S3 and FP8) or 184 mm2 (S2 and FP7); while the double-plate version has a surface area of 364mm2 (B1 and FX1). Aqueous humor passes from the anterior chamber through two thin membrane-like elastomer sheets that theoretically restrict flow until a pressure of greater than 8-12 mm Hg is exerted on them.
In the implantation of GDD, absorbable and non-absorbable sutures are used. Sutures are typically used in securing the plate to the sclera, securing the tube to the sclera, suturing a patch graft or scleral flap over the silicone tube, and for conjunctival closure. Post-surgical course can be marked by discomfort, depending on the type of suture used. Absorbable sutures can induce inflammation with localized surface and subconjunctival fibrosis that leads to uneven conjunctival surface and excessive scarring. On the other hand, non-absorbable sutures can erode through tissue post-operatively. Suturing the conjunctiva can cause button-holes and tears, and can be the most time-intensive portion of the surgery.
Fibrin glue has been used in various ophthalmic surgeries such as a sealant for perforated and preperforated corneal ulcers, in mucous membrane grafts, in the management of complicated hypotony and bleb leaks after trabeculectomy, and for preventing immediate postoperative hypotony after glaucoma drainage implant surgery.
In a paper by Kahook and Noecker published in 2006, the authors did a retrospective non-randomized case-control study that reviewed 28 cases of GDD implantations using traditional suture materials compared to 14 consecutive cases of GDD implantation using Tisseel fibrin glue (Baxter AG, Vienna, Austria) for closing the conjunctiva, securing the pericardium patch graft and securing the tube to the sclera. The authors concluded that Tisseel fibrin glue seems to be a safe substitute for some of the sutures used in GDD surgery; and it has no impact on IOP control or complications. It appears to reduce post-operative conjunctival inflammation and time of surgery.
Optical coherence tomography (OCT) is a high-resolution, non-invasive and reproducible imaging technology that was primarily developed to evaluate the retina and retina nerve fiber layer in patients with vitreo-retinal or optic nerve diseases11. Recently, the anterior segment OCT (AS-OCT) has been developed and used to image anterior segment structures. It has also been used to localize the Ex-PRESS miniature glaucoma implant in porcine eyes, while the conventional OCT was used to show the anterior segment findings after non-penetrating deep sclerectomy and the filtering blebs of eyes that underwent glaucoma filtering surgery.
Patients scheduled for Ahmed Tube surgery, with or without lens extraction and intraocular lens implant, will be recruited and randomized into two groups. The first group of patients will have a pericardial patch graft covering the tube, and fibrin glue will be used to attach the graft to the sclera and to close the conjunctiva. The second group will have a partial- thickness scleral flap raised to cover the tube, and the conjunctiva will be closed with conventional sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- More than 40 years old
- Able to give informed consent
- Diagnosis of any type of glaucoma needing a Glaucoma drainage device (Ahmed tube implant) with or without lens extraction and intraocular lens implant because of uncontrolled intraocular pressures inspite of maximum tolerated medical therapy
Key exclusion criteria (2 listed)
- Inability to give informed consent
- History of ocular infection or inflammation in the past two months
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 |
|---|---|---|
| Pericardial graft & tissue glue | Procedure or surgery | – |
| scleral flap & sutures | Procedure or surgery | – |
Primary outcome
Anterior segment optical coherence tomography appearance and measurements of the overlying conjunctiva, areas above and beneath the pericardial patch graft or partial thickness scleral flap, anterior chamber depth
Intraocular pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
- Background: PubMed 16181273Savini G, Zanini M, Barboni P. Filtering blebs imaging by optical coherence tomography. Clin Exp Ophthalmol. 2005 Oct;33(5):483-9. doi: 10.1111/j.1442-9071.2005.01066.x.
- Background: PubMed 16916877Kahook MY, Noecker RJ. Fibrin glue-assisted glaucoma drainage device surgery. Br J Ophthalmol. 2006 Dec;90(12):1486-9. doi: 10.1136/bjo.2006.101253. Epub 2006 Aug 17.
Related trials for Advanced Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Innovative Tube Trabeculectomy for Advanced and Refractory Glaucoma: A Randomized Controlled Trial
Glaucoma, Trabeculectomy
RecruitingObservational study
Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma
Glaucoma
Active, not recruiting
Minimally Invasive Suprachoroidal Drainage for the Treatment of Neovascular Glaucoma
Neovascular Glaucoma
Recruiting
Feasibility, Accuracy, and Reproducibility of Virtual Reality Visual Field Testing in Patients With Glaucoma
Glaucoma Open-Angle
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 Chew, FRCSEd,MMed 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 2 study testing Pericardial graft & tissue glue and scleral flap & sutures in people with Advanced Glaucoma and Failed Trabeculectomies, 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 3 inclusion and 2 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 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Cecilia Aquino, MD (67725317, cel_aq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior segment optical coherence tomography appearance and measurements of the overlying conjunctiva, areas above and beneath the pericardial patch graft or partial thickness scleral flap, anterior chamber depth. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00453024, which also lists 2 linked publications.
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 14 May 2008.