Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Glaucoma, Angle-Closure
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: multicenter, parallel, open, non-inferior randomized controlled trialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 80 years
Gender
Both males and females

Description

Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method is anti-glaucoma surgery-trabeculectomy (Trab) combined with lens extraction. Phacotrabeculectomy has...

Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method is anti-glaucoma surgery-trabeculectomy (Trab) combined with lens extraction. Phacotrabeculectomy has become the first-line choice of anti-glaucoma suregery in the treatment of advanced PACG. However, it was not an ideal method due to the bleb-related complications and troublesome postoperative nursing, as well as the difficulty for surgeons, caused by trabeculectomy. However, recent studies revealed that the phacoemulsification with intraocular lens implantation (PEI) combined with goniosynechialysis (GSL) has achieved efficacy in the treatment of PACG. With the advent of minimally invasive glaucoma surgeries (MIGS), there is an increasing number studies indicating the MIGS performed great efficacy in the treatment of primary open angle glaucoma. While,there were a few small-sampled retrospective studies which showed therapeutic effects in PACG. The GSL plus goniotomy (GT) could achieve great efficacy in lowering the intraocular pressure of PACG patients. However, there is still a lack of high quality and high-level randomized controlled trials. Therefore, this study intends to conduct a multicenter, parallel, open, non-inferior randomized controlled trial to compare the effectiveness and safety of PEI+ Trab and PEI+GSL+GT in the treatment of advanced PACG, so as to provide a better surgical treatment for PACG.

Tracking Information

NCT #
NCT04878458
Collaborators
  • The Second Affiliated Hospital of Harbin Medical University
  • West China Hospital
  • First Hospital of Shijiazhuang City
  • Union hospital of Fujian Medical University
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Handan City Eye Hospital
Investigators
Principal Investigator: Xiulan Zhang, MD, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University