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Clinical Trials/NCT04878458
NCT04878458Active, not recruitingNot Applicable

Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial

Sun Yat-sen University2 sites in 1 country124 target enrollmentStarted: May 31, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
124
Locations
2
Primary Endpoint
Mean change of intraocular pressure

Study Overview

Brief Summary

A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.

Detailed 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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Mean change of intraocular pressure

Time Frame: Postoperative 12, 24, 36 months.

Change from baseline IOP after surgery using Goldmann or non-contact tonometer.

Secondary Outcomes

  • Intraoperative and postoperative complications(0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months)
  • Anti-glaucomatous medications(0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months)
  • Cumulative success rate of surgery(12, 24, 36 months)

Investigators

Sponsor
Sun Yat-sen University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiulan Zhang

Director of Clinical Research Center

Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Sites (2)

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