Combined Trab+Trab Versus Combined Trab+Trab With Subconjunctival Implantation of Ologen for Primary Congenital Glaucoma

National Centre of Ophthalmology named after academician Zarifa Aliyeva

Status and phase: Unknown; Phase 1

Conditions: Congenital Glaucoma

Treatments: Device: Ologen Collagen Matrix; Procedure: Combined trabeculotomy-trabeculectomy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02121171

Trab+Trab+Ologen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ologen Collagen Matrix Intervention

Experimental group

Description:

Combined trabeculotomy-trabeculectomy with subconjuncitval Ologen matrix implant implantation is a new procedure that has less post operative complications with good results, it is to be applied in children.

Treatment:

Device: Ologen Collagen Matrix

Combined trabeculotomy-trabeculectomy

Active Comparator group

Description:

Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.

Treatment:

Procedure: Combined trabeculotomy-trabeculectomy