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Trabeculectomy With Ologen Collagen Implant vs Trabeculectomy With Provisc in Steroid Induced Glaucoma

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ClinicalTrials.gov Identifier: NCT01912638
Recruitment Status : Completed
First Posted : July 31, 2013
Last Update Posted : September 21, 2016
Sponsor:
Collaborator:
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
National Centre of Ophthalmology named after academician Zarifa Aliyeva

Brief Summary:
The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.

Condition or disease Intervention/treatment Phase
Steroid Induced Glaucoma Device: Ologen Collagen Matrix Drug: Provisc Phase 1 Phase 2

Detailed Description:

Steroid induced glaucoma is a well known and widely described disastrous clinical condition. However the subject of selection of most effective and safe treatment modality is still being discussed.

Sihota R et al reported that 26.5% cases required surgical treatment to control IOP. Unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. Anti-fibrotic agent MMC as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. Additional use of MMC in trabeculectomy leads to low final IOP but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. Tissue-engineered biodegradable and biocompatible implant Ologen® Collagen Matrix may be used as an alternative to MMC. Ologen® is CE Mark and FDA approved artificial porcine extracellular matrix for modulating wound healing. Ologen® has been tested in animal models and has triple action:

  1. prevent the collapse of the subconjunctival space;
  2. guides the fibroblast to grow through the matrix pores thus preventing scar formation;
  3. may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber).

The filtering blebs scoring was performed by using Moorfields Bleb Grading System and Visante anterior segment optical coherence tomography.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma
Study Start Date : July 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Implantation of Ologen in trabeculectomy
Ologen Collagen Matrix is implanted in primary limbal-based trabeculectomy. It should be placed on the top of the loosely-sutured scleral flap before suturing of the conjunctiva thus preventing the collapse of the subconjunctival space.
Device: Ologen Collagen Matrix
Ologen is a porous collagen-glycosaminoglycan matrix that decrease early postoperative scarring after penetrating anti-glaucomatous surgery by randomized collagen deposition and microcyst formation. Implantation of Ologen Collagen Matrix in trabeculectomy was performed.

Active Comparator: Provisc in trabeculectomy
Provisc is used in primary limbal-based trabeculectomy. At the end of the surgery cohesive viscoelastic (Provisc) is injected under the scleral flap to prevent early hypotony.
Drug: Provisc
Provisc is an cohesive viscoelastic.




Primary Outcome Measures :
  1. Intraocular Pressure (IOP) [ Time Frame: 2 years ]

    The absolute success was defined as an IOP less than 21 mmHg with no glaucoma medications.

    Follow-up visits were and will arranged at 1 and 2 first weeks, then every month during first 6 months, then every 3 months during 2.5 years after surgery.



Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 2 years ]
    Complications were defined as follows: hypotony,shallow anterior chamber,serous or hemorrhagic choroidal detachment, hyphema,anterior chamber inflammation,persistent hypotonus maculopathy,corneal epithelial toxicity, "snuff" syndrome,blebitis or endophthalmitis,formation of Tenon's cyst.

  2. Corrected distance visual acuity (CDVA) [ Time Frame: 2 years ]
  3. Appearance of the filtering bleb (FB) [ Time Frame: 2 years ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 16 years (inclusive)
  • Patients with medically uncontrolled steroid induced glaucoma

Exclusion Criteria:

  • Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic, neovascular, or dysgenetic glaucoma
  • Known allergic reaction to porcine collagen
  • Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912638


Locations
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Azerbaijan
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Baku, Azerbaijan, AZ1114
Sponsors and Collaborators
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Aeon Astron Europe B.V.
Investigators
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Study Director: Elmar Kasimov, Professor Director of National Centre of Ophthalmology
Principal Investigator: Fidan Aghayeva, MD Glaucoma consultant at National Centre of Ophthalmology

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Responsible Party: National Centre of Ophthalmology named after academician Zarifa Aliyeva
ClinicalTrials.gov Identifier: NCT01912638     History of Changes
Other Study ID Numbers: Trab-Olo-SG
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: July 2015
Keywords provided by National Centre of Ophthalmology named after academician Zarifa Aliyeva:
Trabeculectomy
Glaucoma
Steroids
Ologen
Viscoelastic
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents