Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 6 for:    Recruiting, Not yet recruiting, Available Studies | Hydrophthalmos

Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541551
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Sirisha Senthil, L.V. Prasad Eye Institute

Brief Summary:
To the best of Investigator knowledge, no studies to this date have compared the safety and efficacy of ologen® Collagen Matrix in Primary congenital glaucoma (PCG) patients undergoing trabeculectomy. Given that filtration surgery is usually less successful in patients with developmental glaucoma; the purpose of this study is to compare combined trabeculectomy with trabeculotomy (CTT) with adjuvant ologen® Collagen Matrix versus CTT without ologen® in children with PCG. Investigator hypothesis is that CTT with ologen® Collagen Matrix would be as effective as CTT in IOP control, but with reduced scarring and long term healthier bleb morphology.

Condition or disease Intervention/treatment Phase
Primary Congenital Glaucoma Developmental Glaucoma Infantile Glaucoma Procedure: CTT with ologen® Collagen Matrix Procedure: Trab Trab Not Applicable

Detailed Description:

Standard combined trabeculectomy with trabeculotomy (CTT) All CTT surgeries will be performed under general anesthesia.Under aseptic surgical technique, a superior rectus suture will be placed using 4'0 silk and a limbal-based conjunctival flap to be performed. Sub-Tenon dissection and hemostasis will be achieved and a half-thickness 4 x 4mm rectangular scleralflap will to be dissected up to clear cornea, and radial incision will be placed at the location of the schemes canal, Harms trabepculotome will be used to pass into the schemes canal and rotated into the anterior chamber to open app 60 degree on either sides, A 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one 10-0 nylon suture and conjunctiva will be closed with 8-0 vicryl continuous suture.

The same procedure will be done for the CTT with ologen® except, before closing the conjunctiva, the ologen® implant will be placed subconjunctivally just overlapping the apex of the triangular scleral flap

ologen® Collagen Matrix ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 (valid till Mar-15-2018) will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Product:ologen® Collagen Matrix, Model: 830601, Shape:Round cylindrical, Size:6mm (diameter) x 2mm (thickness, Manufacturer: Aeon Astron Europe B. V.
Masking: Double (Participant, Investigator)
Masking Description: Eligible patient after screening will be assigned consecutive randomization numbers in ascending order upon enrollment. The patient will be randomized in 1:1ratio to one of two study groups, namely combined trabeculotomy with trabeculectomy with ologen® Collagen Matrix as adjunctive wound modulator(Group A) or combined trabeculotomy with trabeculectomy alone without any adjunctive (Group B). The assigned randomization number will be recorded in each subject's DCF. The randomization scheme will be generated using random function in excel before patient enrollment in order to avoid investigator's patient selection bias.
Primary Purpose: Treatment
Official Title: Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix in Patients With Primary Congenital Glaucoma Undergoing Trabeculectomy
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019


Arm Intervention/treatment
Experimental: CTT with ologen® Collagen Matrix
Experimental: Trabeculotomy with trabeculectomy with ologen implant
Procedure: CTT with ologen® Collagen Matrix
ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.
Other Name: Ologen with combined trabeculotomy and trabeculectomy

Active Comparator: Trab Trab
Active Comparator: Trabeculotomy with trabeculectomy
Procedure: Trab Trab
combined trabeculotomy with trabeculectomy
Other Name: combined trabeculotomy with trabeculectomy




Primary Outcome Measures :
  1. Comparing IOP control between the two groups:Change of intraocular pressure (IOP) over time [ Time Frame: 12 months ]
    Assess control of IOP over time. "Complete success" is defined as IOP reduction of >20% and / or an IOP constantly <21 mmHg without any antiglaucoma medication. "Qualified success" is defined as IOP < 21 mmHg with topical antiglaucoma medication. "Failure" is defined as IOP > 21mmHg in 2 subsequent follow visits despite topical antiglaucoma medication.


Secondary Outcome Measures :
  1. Comparing bleb morphology in two groups by change of Moorfields Bleb Grading System (MBGS) score over time [ Time Frame: 12 months ]
    Assess bleb characteristics using Moorfields Bleb Grading System (MBGS) score as measurement tool to document bleb grading score over time, clinically and with photographs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 1 month to 3 years (inclusive)
  • Any case diagnosed as congenital glaucoma (with enlarged corneal diameter more than 11 mm, including corneal edema or Haab'sstria with or without optic disc cupping, IOP>12 mm Hg)
  • Parents of the patientis willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

  • Patients withany other types of secondary glaucoma
  • Patients with any other ocular disease

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): NCT03541551


Contacts
Layout table for location contacts
Contact: Thiruttani Charitha, Msc 040 30612124 charitha@lvpei.org

Sponsors and Collaborators
L.V. Prasad Eye Institute
Investigators
Layout table for investigator information
Principal Investigator: senthil sirisha, MS YES

Layout table for additonal information
Responsible Party: Dr. Sirisha Senthil, Consultant-Ophthalmologist, L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier: NCT03541551     History of Changes
Other Study ID Numbers: IIS-90516
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases