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Satinder Pal Singh Grewal MD

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Title: Satinder Pal Singh Grewal MD


1
Safety and Efficacy of OculusGen Biodegradable
Collagen Matrix Implant in Phacotrabeculectomy
Surgery
Satinder Pal Singh Grewal MD Rajeev Jain, MD
Dilraj Grewal MBBS Gagandeep S Brar MD
GREWAL EYE INSTITUTE CHANDIGARH, INDIA
2
Financial Disclosures
None of the authors have any financial interest
in this presentation
3
Purpose
  • 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.

This study was registered with ClinicalTrials.gov
Identifier NCT00477685
4
Introduction
  • Long-term intraocular pressure (IOP) control
    following trabeculectomy may be limited by
    filtration failure, due to scarring at the level
    of the conjunctiva-Tenons-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.
    197886345349.
  • Stamper RL, McMenemy MG, Lieberman MF. Hypotonous
    maculopathy after trabeculectomy with
    subconjunctival 5-fluorouracil. Am J Ophthalmol.
    1992114544553
  • Sinnreich Z, Barishak R, Stein R. Leaking
    filtering blebs. Am J Ophthalmol.
    197886345349.

5
Introduction
  • 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.
  • 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. 198986933937.
  • Yannas IV. Studies on the biological activity of
    the dermal regeneration template. Wound Repair
    Region. 19986518524.
  • Chen HS, Ritch R, Krupin T, Hsu WC. Control of
    filtering bleb structure through tissue
    bioengineering An animal model.Invest Ophthalmol
    Vis Sci. 2006 Dec47(12)5310-4.
  • Young MJ, Borras T, Walter M, Ritch R (2005)
    Potential applications of tissue engineering to
    glaucoma. Arch Ophthalmol 1231725173
  • 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

6
StructureBiodegradable Collagen Matrix Implant
  • 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.

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.
Scanning electron microscopic image of collagen
matrix.
7
Methods
  • 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).

8
Methods
Inclusion Criteria
Exclusion Criteria
  • 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
  • Age 30 years or older
  • No previous intraocular surgery
  • Uncontrolled glaucoma, with failed medical and
    laser treatment, requiring trabeculectomy.

9
Surgical Method of Implantation
Graphics from www.oculusgen.com
10
Surgical Method of Implantation
  • 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.
  • 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

Graphics from www.oculusgen.com
11
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 lt
    0.05) to 16.3 2.1 mmHg.
  • There were no significant intra-operative or
    post-operative complications in any patients.

12
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.
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