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

NCT02121171 | Unknown Phase 1 DMC

• 1 other identifier: Trab+Trab+Ologen
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative complications and appearances.

  At postoperative up to 24 months.

Study Arms (2)

Ologen Collagen Matrix Intervention

EXPERIMENTAL

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

Combined trabeculotomy-trabeculectomy

ACTIVE COMPARATOR

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

Procedure: Combined trabeculotomy-trabeculectomy

Interventions

Ologen Collagen Matrix 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.

Ologen Collagen Matrix Intervention

Combined trabeculotomy-trabeculectomy PROCEDURE

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

Combined trabeculotomy-trabeculectomy

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Centre of Ophthalmology named after academician Zarifa Aliyeva: lead
• Aeon Astron Europe B.V.: collaborator

Study Sites (1)

National Centre of Ophthalmology

Baku, Azerbaijan

Location

MeSH Terms

Conditions

Hydrophthalmos

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Nigar Makhmudova

  Ophthalmologist at National Centre of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2014
• First Posted: April 23, 2014
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 21, 2015

Record last verified: 2015-07

Locations

AZ (1)