Imaging Ahmed Glaucoma Tubes With a Pericardial Graft and Tissue Glue or Partial-Thickness Scleral Flap and Sutures
Primary Purpose
Advanced Glaucoma, Failed Trabeculectomies
Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Pericardial graft & tissue glue
scleral flap & sutures
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Glaucoma focused on measuring Advanced glaucoma, Ahmed glaucoma implant, Anterior segment optical coherence tomography, Pericardial patch graft, Tissue glue, Scleral flap, Sutures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to give informed consent
- History of ocular infection or inflammation in the past two months
Sites / Locations
- National University HospitalRecruiting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00453024
First Posted
March 27, 2007
Last Updated
May 12, 2008
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT00453024
Brief Title
Imaging Ahmed Glaucoma Tubes With a Pericardial Graft and Tissue Glue or Partial-Thickness Scleral Flap and Sutures
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Glaucoma, Failed Trabeculectomies
Keywords
Advanced glaucoma, Ahmed glaucoma implant, Anterior segment optical coherence tomography, Pericardial patch graft, Tissue glue, Scleral flap, Sutures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pericardial graft & tissue glue
Intervention Type
Procedure
Intervention Name(s)
scleral flap & sutures
Primary Outcome Measure Information:
Title
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
Title
Intraocular pressure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Inability to give informed consent
History of ocular infection or inflammation in the past two months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecilia Aquino, MD
Phone
67725317
Email
cel_aq@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Chew, FRCSEd,MMed
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jovina See, MMed,FRCS
First Name & Middle Initial & Last Name & Degree
Cecilia Aquino, MD
First Name & Middle Initial & Last Name & Degree
Grace Dizon, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16181273
Citation
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.
Results Reference
background
PubMed Identifier
16916877
Citation
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.
Results Reference
background
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Imaging Ahmed Glaucoma Tubes With a Pericardial Graft and Tissue Glue or Partial-Thickness Scleral Flap and Sutures
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