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Satinder Pal Singh Grewal MD
Rajeev Jain, MD
Dilraj Grewal MBBS
Gagandeep S Brar MD
Safety and Efficacy of OculusGen Biodegradable
Collagen Matrix Implant in Phacotrabeculectomy
Surgery
GREWAL EYE INSTITUTECHANDIGARH, INDIA
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Financial Disclosures
None of the authors have any financial interest in this presentation
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• To present the preliminary results of a pilot study that evaluating the safety
and efficacy of OculusGen Biodegradable Collagen Matrix Implant designed to improve the regenerating tissue-remodeling in glaucoma patients with cataract undergoing combined phacotrabeculectomy surgery.
Purpose
This study was registered with ClinicalTrials.gov: Identifier NCT00477685
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• Long-term intraocular pressure (IOP) control following trabeculectomy may be limited by filtration failure, due to scarring at the level of the conjunctiva-Tenon’s-episcleral interface, the scleral flap or its overlying episclera, or the internal ostium
• Clinically, mitomycin-C (MMC), 5-fluorouracil, and corticosteroids have all been used to inhibit fibroblast proliferation to prevent scar development after glaucoma surgery.However they are associated with the risk for late postoperative complications, including wound leakage, hypotony, and maculopathy.1,2,3
• Sinnreich Z, Barishak R, Stein R. Leaking filtering blebs. Am J Ophthalmol. 1978;86:345–349.• Stamper RL, McMenemy MG, Lieberman MF. Hypotonous maculopathy after trabeculectomy with subconjunctival 5-fluorouracil. Am J Ophthalmol.
1992;114:544–553• Sinnreich Z, Barishak R, Stein R. Leaking filtering blebs. Am J Ophthalmol. 1978;86:345–349.
Introduction
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• The use of tissue bioengineering to prevent scar prevention has been
described.4,5,6,7 The application of three-dimensional, collagen-
glycosaminoglycan copolymers can lead to random and relatively loose
reorganization of regenerating myofibroblasts, fibroblasts, and the secreted
extracellular matrix (i.e., collagen), reducing scar formation.
• These biodegradable implants may simultaneously provide physical
resistance to overfiltration in the early stages and progressively may reduce
this resistance as the implant degrades and a random connective tissue
matrix permeates the spaces within the implant to create a loosely organized
bleb structure.
Introduction
• Yannas IV, Lee E, Orgill DP, Skrabut EM, Murphy GF. Synthesis and characterization of a model extracellular matrix that induces partial regeneration of adult mammalian skin. Proc Nat Acad Sci USA. 1989;86:933–937.
• Yannas IV. Studies on the biological activity of the dermal regeneration template. Wound Repair Region. 1998;6:518–524. • Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model.Invest Ophthalmol Vis Sci. 2006
Dec;47(12):5310-4.• Young MJ, Borras T, Walter M, Ritch R (2005) Potential applications of tissue engineering to glaucoma. Arch Ophthalmol 123:1725–173• Hsu WC, Ritch R, Krupin T, Chen HS. Tissue bioengineering for surgical bleb defects: an animal study. Graefes Arch Clin Exp Ophthalmol. 2008 Feb 12
[Epub ahead of print]
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Structure:Biodegradable Collagen Matrix Implant
Scanning electron microscopic image of collagen matrix. A drug-free, biodegradable, porous collagen
matrix of 1% collagen/C-6-S copolymer
(OloGen) with a 7-mm diameter and a 4-mm
thickness was used.
• In this study a three-dimensional biodegradable collagen matrix was placed in the subconjunctival space and on
top of the scleral flap to achieve better postoperative IOP control and to reduce the risk for early shallow anterior
chamber.
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• 5 patients underwent combined trabeculectomy with the OculusGen Biodegradable Collagen Matrix Implant in one eye for refractory glaucoma
• Refractory glaucoma was defined as having previously failed medical, laser or surgical treatment, and phacoemulsifcation with Acrylic IOL impant (AMO AR-40).
• The OculusGen was implanted on the top of the scleral flap at the limbus before closing the conjunctival wound during trabeculectomy operations.
• Intraocular pressure (IOP), bleb characteristics and post-operative complications were assessed before and after surgery.
• Bleb photographs were analyzed at all post-operative visits according to the Moorfields Bleb-Grading System for the parameters of area (grades 1-5), height (grades 1-4) and vascularity (grades 1-5).
Methods
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•Age 30 years or older
•No previous intraocular surgery
•Uncontrolled glaucoma, with failed
medical and laser treatment, requiring
trabeculectomy.
•Known allergic reaction to porcine collagen.
•Subject is on warfarin and discontinuation is not
recommended.
•Patients with:
•Normal tension glaucoma,
•Uveitic glaucoma,
•Sphakic or pseudophakic glaucoma,
•Neovascular glaucoma
•Secondary glaucoma.
•Ocular infection within 14 days prior to
trabeculectomy.
•Pregnant or breast-feeding women
Inclusion Criteria: Exclusion Criteria:
Methods
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Surgical Method of Implantation
Graphics from www.oculusgen.com
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Surgical Method of Implantation
Graphics from www.oculusgen.com
1. Hsu WC, Ritch R, Krupin T, Chen HS. Tissue bioengineering for surgical bleb defects: an animal study. Graefes Arch Clin Exp Ophthalmol. 2008 Feb 12 [Epub ahead of print]
•Positioning of implant in respect to the
scleral flap and the conjunctival wound.
•Double arrow points to Conjunctival
defect over the area above the implant.
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Results
•The study population included 4 Males and 1 Female
•Average age was 56.3 ± 9.6 yrs
The mean preoperative IOP was
35.7 ± 7.8 mmHg.
Postoperatively, the mean IOP at 4
months follow-up for all eyes had a
54.3% reduction (p < 0.05) to 16.3
±2.1 mmHg.
There were no significant intra-
operative or post-operative
complications in any patients.
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Conclusions
• The short-term preliminary results of this study indicate that the OculusGen
implantation in combined phaco-trabeculectomy could potentially provide a
safe and effective therapeutic preventing wound failure following
trabeculectomy surgery.
•The OculusGen helps to modulate wound healing response following
glaucoma filtering surgery.
•However a larger study with a longer follow-up period is required to confirm
these observations.
•Biodegradable Collagen Matrix implants can help in achieving a successful
trabeculectomy without antifibrotic medication,controlling both the physical
and physiologic aspects of wound healing.