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

NCT ID: NCT02121171

Last Updated: 2015-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed 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.

Conditions

Congenital Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ologen Collagen Matrix Intervention

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.

Group Type: EXPERIMENTAL

Ologen Collagen Matrix

Intervention Type: DEVICE

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.

Combined trabeculotomy-trabeculectomy

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

Group Type: ACTIVE_COMPARATOR

Combined trabeculotomy-trabeculectomy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

Combined trabeculotomy-trabeculectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeon Astron Europe B.V.

INDUSTRY

Sponsor Role: collaborator

National Centre of Ophthalmology named after academician Zarifa Aliyeva

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nigar Makhmudova

Role: PRINCIPAL_INVESTIGATOR

Ophthalmologist at National Centre of Ophthalmology

Locations

National Centre of Ophthalmology

Baku, , Azerbaijan

Countries

Azerbaijan

Other Identifiers

Trab+Trab+Ologen

Identifier Type: -

Identifier Source: org_study_id