Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy
Condition: Primary Congenital Glaucoma; Developmental Glaucoma; Infantile Glaucoma
MeSH terms: Glaucoma; Hydrophthalmos
Study type: Interventional

Summary: 
      To the best of Investigator knowledge, no studies to this date have compared the safety and
      efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing
      trabeculectomy. Given that filtration surgery is usually less successful in patients with
      developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with
      trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in
      children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be
      as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb
      morphology.
    

Detailed description: 
      Standard combined trabeculectomy with trabeculotomy (CTT) All CTT surgeries will be performed
      under general anesthesia.Under aseptic surgical technique, a superior rectus suture will be
      placed using 4'0 silk and a limbal-based conjunctival flap to be performed. Sub-Tenon
      dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular
      scleralflap will to be dissected up to clear cornea, and radial incision will be placed at
      the location of the schemes canal, Harms trabepculotome will be used to pass into the schemes
      canal and rotated into the anterior chamber to open app 60 degree on either sides, A 2 × 2 mm
      deep scleral block will be excised and peripheral iridectomy will be performed. The scleral
      flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl
      continuous suture.

      The same procedure will be done for the CTT with ologen® except, before closing the
      conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex
      of the triangular scleral flap

      ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with
      registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India
      Pvt. Ltd. free of cost for this clinical research only.
    

Intervention name(s): CTT with ologen® Collagen Matrix; Trab Trab
Intervention type(s): Procedure; Procedure
Intervention description(s): ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.; combined trabeculotomy with trabeculectomy
Other intervention name(s): Ologen with combined trabeculotomy and trabeculectomy; combined trabeculotomy with trabeculectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Product:ologen® Collagen Matrix, Model: 830601, Shape:Round cylindrical, Size:6mm (diameter) x 2mm (thickness, Manufacturer: Aeon Astron Europe B. V.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment