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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

Tracking Information
First Submitted Date  ICMJE April 19, 2014
First Posted Date  ICMJE April 23, 2014
Last Update Posted Date July 21, 2015
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Trab+Trab Versus Combined Trab+Trab With Subconjunctival Implantation of Ologen for Primary Congenital Glaucoma
Official Title  ICMJE Comparative Evaluation of Combined Trabeculotomy-trabeculectomy Versus Combined Trabeculotomy-trabeculectomy With Subconjunctival Implantation of Collagen Matrix Implant for Primary Congenital Glaucoma.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Congenital Glaucoma
Intervention  ICMJE
  • 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.
  • Procedure: Combined trabeculotomy-trabeculectomy
    Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Ologen Collagen Matrix
  • Active Comparator: Combined trabeculotomy-trabeculectomy
    Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.
    Intervention: Procedure: Combined trabeculotomy-trabeculectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Azerbaijan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02121171
Other Study ID Numbers  ICMJE Trab+Trab+Ologen
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Centre of Ophthalmology named after academician Zarifa Aliyeva
Study Sponsor  ICMJE National Centre of Ophthalmology named after academician Zarifa Aliyeva
Collaborators  ICMJE Aeon Astron Europe B.V.
Investigators  ICMJE
Principal Investigator: Nigar Makhmudova Ophthalmologist at National Centre of Ophthalmology
PRS Account National Centre of Ophthalmology named after academician Zarifa Aliyeva
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP