NCT02964676

Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Primary Angle Closure Glaucoma

Clinical Efficacy and Safety of Minimally Invasive Glaucoma Surgery on Chinese Primary Angle Closure Glaucoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 246 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the clinical efficacy (intraocular pressure reduction , success rate, the number of antiglaucoma medication) and safety of ab interno trabeculectomy (AIT) with Trabectome in Chinese PACG .

Detailed description

A randomized, single blind, positive parallel control study method was used.This prospective case series will recruit 246 Chinese POAG, 123 cases in the experimental group will receive AIT treatment and 123 cases in the control group will receive trabeculectomy(Trab) surgery.Measurements of intraocular pressure(IOP) , visual acuity, refraction, slit lamp examination of the anterior segment and fundus, optical coherence tomography(OCT) to detect retinal nerve fiber layer thickness, macular thickness, visual field, gonioscopy and ultrasonic biological microscopy (UBM) will be recorded.They will be followed up for 12 months. The main outcome is success rate of IOP reduction and the other outcome are the number of antiglaucoma medication and complications .

Conditions

• Glaucoma, Angle-Closure

Interventions

Type	Name	Description
PROCEDURE	ab interno trabeculectomy with Trabectome	123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly
PROCEDURE	trabeculectomy	123 PACG will be recruited to receive trabeculectomy to reduce IOP

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-11-16
• Last updated: 2016-11-28