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

Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Glaucoma
• Intervention / Treatment: Device: Ologen Collagen Matrix; Procedure: Combined trabeculotomy-trabeculectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Azerbaijan
  • Baku, Azerbaijan
    • National Centre of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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-trabeculectomy; Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.	Procedure: Combined trabeculotomy-trabeculectomy; Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular pressure(IOP) reduction	"Complete success" is consider for IOP less than 21mmHg(inclusive) with no glaucoma medications and with more than 20% reduction(inclusive) from baseline IOP. Definition of success rate is calculated in percentage by the number of complete success patients over the total sample size. "Qualified success" that meets the postoperative IOP requirements with postoperative glaucoma medicaitons and "Failure" of meeting the IOP requirements are the other efficacy parameters. In the specified time frame, patients will also visit for record at day 7, 30, 90, 180 days, 12, 18, and 24 months.	At postoperative up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications and appearances.	Inspections of hyphema, severe anterior chamber reaction, hypotony, supracholoidal hemorrhage, flat anterior chamber, endophthalmitis, choroidal detachment, wound or bleb leak. Visual acuity (if possible), bleb appearance, and anterior chamber inflammation.	At postoperative up to 24 months.

Collaborators and Investigators

• Sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva
• Collaborators: Aeon Astron Europe B.V.
• Investigators: Principal Investigator: Nigar Makhmudova, Ophthalmologist at National Centre of Ophthalmology

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: April 19, 2014
• First Submitted That Met QC Criteria: April 19, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): July 21, 2015
• Last Update Submitted That Met QC Criteria: July 18, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Congenital Abnormalities; Ocular Hypertension; Eye Abnormalities; Glaucoma, Open-Angle; Infant, Newborn, Diseases; Glaucoma; Hydrophthalmos
• Other Study ID Numbers: Trab+Trab+Ologen

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No