This trial is active, not recruiting.

Condition congenital glaucoma
Treatments ologen collagen matrix, combined trabeculotomy-trabeculectomy
Phase phase 1
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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.
ologen collagen matrix
Use of ologen Collagen Matrix in trabeculectomy (ologen) Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
(Active Comparator)
Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.
combined trabeculotomy-trabeculectomy
Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.

Primary Outcomes

Intraocular pressure(IOP) reduction
time frame: At postoperative up to 24 months

Secondary Outcomes

Postoperative complications and appearances.
time frame: At postoperative up to 24 months.

Eligibility Criteria

Male or female participants from 6 months up to 12 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by National Centre of Ophthalmology named after academician Zarifa Aliyeva.