Combined Trab+Trab Versus Combined Trab+Trab With Subconjunctival Implantation of Ologen for Primary Congenital Glaucoma
This trial is active, not recruiting.
|Treatments||ologen collagen matrix, combined trabeculotomy-trabeculectomy|
|Sponsor||National Centre of Ophthalmology named after academician Zarifa Aliyeva|
|Collaborator||Aeon Astron Europe B.V.|
|Start date||September 2010|
|End date||September 2015|
|Trial size||40 participants|
|Trial identifier||NCT02121171, Trab+Trab+Ologen|
The objective of this prospective randomised study is to compare the efficacy and safety of ologen CM (Collagen matrix) as adjunct to combined trabeculotomy-trabecuectomy in congenital glaucoma cases, the efficacy being the primary objective and the safety being the secondary. The investigators hypothesize that combined trabeculotomy-trabecuectomy with Ologen collagen matrix implant implantation in congenital glaucoma is a safer procedure and may yield better results than combined trabeculotomy-trabeculectomy approach.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Intraocular pressure(IOP) reduction
time frame: At postoperative up to 24 months
Postoperative complications and appearances.
time frame: At postoperative up to 24 months.
Male or female participants from 6 months up to 12 years old.
- Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Haab's stria with or without optic disc cupping. Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities. Within the age of (0 - 12).
- Cases of congenital glaucoma with previous intervention. Age above 12 Yrs. Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
|Official title||Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.|
|Principal investigator||Nigar Makhmudova|
|Description||"Ologen ® CM" is a biodegradable collagen matrix. To prevent episcleral fibrosis and subconjunctival scarring thay may result in the surgical failure in filtration surgery, its sporous matrix modulates the migrations and proliferations of fibroblasts to create a vascular and long-lasting bleb without the adverse effects. Results of ologen CM studies have been published at conferences and published in peer-reviewed journals; ologen CM is approved in Europe as an aid for tissue repair, and by the FDA in the US as an adjunct in wound management(K080868). In general, over 7,000 ologen CM have been implanted worldwide during the past two years with good results and excellent safety profile.|
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