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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary: 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 .
Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Current Primary Outcome: success rate of IOP reduction [ Time Frame: 12 months ]

IOP ≤21mmHg and IOP reduction rate ≥20% with or without antiglaucoma medications and without additional glaucoma surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of antiglaucoma medication [ Time Frame: 12 months ]
    numbers of antiglaucoma medication will be recorded before surgery and 12 months follow up.
  • complication rate [ Time Frame: 12 months ]
    all the complications related to the surgery will be evaluated and recorded.
  • 24-hour IOP fluctuations [ Time Frame: 12 months ]
    24-hour IOP fluctuations curve will be recorded before treatment and 12 months follow up.


Original Secondary Outcome: Same as current

Information By: Shanghai Eye Disease Prevention and Treatment Center

Dates:
Date Received: November 14, 2016
Date Started: January 2017
Date Completion: December 2019
Last Updated: November 23, 2016
Last Verified: November 2016