Randomized Controlled Study to Evaluate Safety and Efficacy of Ologen® Collagen Matrix Versus Mitomycin-C in Patients With Juvenile-onset Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Intraocular pressure control in the two groups will be compared.
研究概览
简要总结
To the best of Investigator knowledge, no studies to this date have compared the safety and efficacyof ologen® Collagen Matrix to MMC in exaggerated healing response among JOAG patients. Given that,filtration surgery is usually less successful in patients with juvenile glaucoma; the purpose of this study is to compare these two adjuvant therapies in exaggerated healing response among JOAG patients. Investigator hypothesis is that trabeculectomy with ologen® Collagen Matrix would be as effective as MMC in IOP control, with prominent bleb morphology as compared to MMC bleb.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 10 to 40 years (inclusive)
- •Uncontrolled IOP (defined as IOP > 21 mm Hg) despite maximum tolerable antiglaucoma therapy
- •Open anterior chamber angle on gonioscopic examination
- •Glaucomatous optic disc damage on clinical examination (focal or diffuse neuroretinal rim thinning, localized notching or nerve fiber layer defects) with corresponding visual field (VF) defects
- •Patientor his/her guardian is willing and able to comply with study procedures and sign informed consent
排除标准
- •Patients with steroid-induced glaucoma and other types of secondary open angle glaucoma
- •Juvenile-onset Open Angle Glaucoma eyes that underwent trabeculectomy with MMC or had a previous filtering surgery
- •Patients with any other ocular disease that may expose them to an undue risk of a significant adverse event during the course of the study, including but not limited to ocular cancer, trauma, corneal surface damage or other conditions as determined by the clinical judgment of the investigator
- •Patient with single functional eye
- •Participation in any study 30 days prior to trabeculectomy
- •Pregnant or breast-feeding women
结局指标
主要结局
Intraocular pressure control in the two groups will be compared.
时间窗: 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.
次要结局
- Bleb morphology:Change of Moorfields Bleb Grading System (MBGS) score over time(at 3 months, 6 months and 1 year)
研究者
HERF
Consultant-Ophthalmologist
L.V. Prasad Eye Institute