Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
|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: NCT03548805|
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma||Procedure: ologen® Collagen Matrix Procedure: Trabeculectomy with low dose mitomycin C||Not Applicable|
Standard trabeculectomy All trabeculectomy surgeries will be performed under peribulbar anesthesia.Under aseptic surgical technique, superior rectus suture will be placed using 4-0 silk and a fornix-based conjunctival flap will be performed. Sub-Tenon dissection and hemostasis may be performed as required.A half-thickness 4 x 4mm rectangular/ triangular scleral flap will be dissected up to clear cornea, and a 2 × 2 mm deep scleral block will be excised and peripheral iridectomy will be performed. The scleral flap will be closed with one or two 10-0 nylon sutures and conjunctiva will be closed with 8-0 vicryl suture. Releasable sutures may be applied to the scleral flap if needed.
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.
The following table summarizes the model number, shape and manufacturer of ologen® Collagen Matrix to be used in this clinical research.
Product Model Shape Size Manufacturer Country of Origin Product Registration ologen® Collagen Matrix 830601 Round cylindrical 6mm (diameter) x 2mm (thickness) Aeon Astron Europe B. V. The Netherlands MD-1517 (valid till Mar-15-2018)
Mitomycin C Mitomycin-C Kyowa®; Kyowa Hakko Kogyo Co., Ltd. will be used. 0.02% solution of MMC will be prepared freshly on the day of planned surgery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||ologen® Collagen Matrix, Model 830601, shape Round cylindrical, Size 6mm (diameter) x 2mm (thickness),Manufacturer Aeon Astron Europe B. V.|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2019|
Experimental: Trabeculectomy with Ologen
ologen® Collagen Matrix
Procedure: ologen® Collagen Matrix
Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs
Active Comparator: Trabeculectomy with low dose mitomycin C
Trabeculectomy with low dose MMC (0.02%)
Procedure: Trabeculectomy with low dose mitomycin C
Trabeculectomy with low dose MMC
- Intraocular pressure control in the two groups will be compared. [ Time Frame: 1 year ]Comparison of IOP control between the two groups: 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.
- Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time [ Time Frame: at 3 months, 6 months and 1 year ]Assess bleb characteristics using Moorfields Bleb Grading System (MBGS) score as measurement tool to document bleb grading score over time; and comparison of bleb morphology in the two groups with photographs and ASOCT
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548805
|Contact: Thiruttani Charitha, Msc||040 firstname.lastname@example.org|
|Principal Investigator:||Senthil Sirisha, MS||YES|