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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Cecilia Aquino, MD contact

67725317

cel_aq@yahoo.com

Singapore1 site, 1 recruiting
  • National University Hospital

    Singapore, 119074

    Jovina See, MMed,FRCS

    Cecilia Aquino, MD

    Recruiting

Other trials in Singapore

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.

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.

  1. 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

  2. Intraocular pressure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Study completionMar 2008 (estimated)

Resources

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)
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 16181273
  • Kahook 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

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.

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