Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
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|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 email@example.com|
|Principal Investigator:||Senthil Sirisha, MS||YES|