Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study)

Abstract

IntroductionPrimary angle-closure glaucoma (PACG) is a major subtype of glaucoma that accounts for most bilateral glaucoma-related blindness globally. Filtering surgery is a conventional strategy for PACG, yet it has a long learning curve and undesirable disastrous complications. Minimally invasive glaucoma surgery (MIGS) plays an increasing role in the management of glaucoma due to its safer and faster recovery profile; cataract surgery-based MIGS is the most commonly performed such procedure in PACG. However, for patients with a transparent lens or no indications for cataract extraction, incorporation of MIGS into PACG treatment has not yet been reported. Therefore, this multicentre, non-inferiority, randomised controlled clinical trial aims to compare the efficacy and safety of trabeculectomy versus peripheral iridectomy plus an ab interno goniotomy in advanced PACG with no or mild cataracts.Methods and analysisThis non-inferiority, multicentre, randomised controlled trial will be conducted at seven ophthalmic departments and institutes across China. Eighty-eight patients with no or mild cataracts and advanced PACG will be enrolled and randomised to undergo trabeculectomy or peripheral iridectomy plus ab interno goniotomy. Enrolled patients will undergo comprehensive ophthalmic examinations before and after surgery. The primary outcome is intraocular pressure (IOP) at 12 months postoperatively. The secondary outcomes are cumulative success rate of surgery, surgery-related complications and number of IOP-lowering medications. Participants will be followed up for 36 months postoperatively.Ethics and disseminationThe study protocol was approved by the ethical committees of the Zhongshan Ophthalmic Center, Sun Yat-sen University, China (ID: 2021KYPJ191) and of all subcentres. All participants will be required to provide written informed consent. The results will be published in peer-reviewed journals and disseminated in international academic meetings.Trial registration numberNCT05163951.

Minimally Invasive Glaucoma Surgery in Primary Angle-Closure Glaucoma

“…Large scale, multicentered RCTs are needed to assess the effectiveness of MIGS in PACG, particularly in eyes with advanced disease. Two RCTs comparing the efficacy and safety of trabeculectomy or phacotrabeculectomy versus MIGS in advanced PACG: phacotrabeculectomy versus phacogoniotomy in Advanced Primary Angle-Closure Glaucoma (Clin-icalTrials.gov; identifier: NCT04878458); 115 and Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG (TVG) (ClinicalTrials.gov; identifier: NCT05163951) 116 are ongoing. Additional studies are needed to investigate the indications and benefits of MIGS in PACG.…”