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

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ClinicalTrials.gov Identifier: NCT02121171
Recruitment Status : Unknown
Verified July 2015 by National Centre of Ophthalmology named after academician Zarifa Aliyeva.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : July 21, 2015
Sponsor:
Collaborator:
Aeon Astron Europe B.V.
Information provided by (Responsible Party):
National Centre of Ophthalmology named after academician Zarifa Aliyeva

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.

Condition or disease Intervention/treatment Phase
Congenital Glaucoma Device: Ologen Collagen Matrix Procedure: Combined trabeculotomy-trabeculectomy Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.
Study Start Date : September 2010
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015


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.




Primary Outcome Measures :
  1. Intraocular pressure(IOP) reduction [ Time Frame: At postoperative up to 24 months ]

    "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.



Secondary Outcome Measures :
  1. Postoperative complications and appearances. [ Time Frame: At postoperative up to 24 months. ]

    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.




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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121171


Locations
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Azerbaijan
National Centre of Ophthalmology
Baku, Azerbaijan
Sponsors and Collaborators
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Aeon Astron Europe B.V.
Investigators
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Principal Investigator: Nigar Makhmudova Ophthalmologist at National Centre of Ophthalmology

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Responsible Party: National Centre of Ophthalmology named after academician Zarifa Aliyeva
ClinicalTrials.gov Identifier: NCT02121171     History of Changes
Other Study ID Numbers: Trab+Trab+Ologen
First Posted: April 23, 2014    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases