Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    124
  • sponsor
    Sun Yat-sen University
Updated on 17 September 2021

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.

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.

Details
Condition Angle Closure Glaucoma
Treatment phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy, phacoemulsification with intraocular lens implantation combined with trabeculectomy
Clinical Study IdentifierNCT04878458
SponsorSun Yat-sen University
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 40-80
Diagnosed with advanced PACG
meet with (1) (2) (3) or (1) (2) (4) (1) more than 180-degree synechial
closure of anterior chamber angle on gonioscopy; (2) IOP> 21mmHg (Goldmann
applanation), with or without anti-glaucoma medication; (3) Significant
glaucomatous optic neuropathy [cup-to-disc (C/D)ratio0.7, or C/D asymmetry >
2, or the rim width at superior and inferior temporal < 0.1 vertical
diameters of optic disc); (4) With glaucoma visual field defects, such as
nasal step, arcurat defect, and paracentral scotoma (on reliable Humphrey
analyzer using SITA-Standard 24-2 or 30-2 algorithm); mead deviation -12dB)
\. Patients with clinically significant cataracts with a visual acuity of
less than 0.63 (ETDRS LogMAR), or need lens extraction assessed by an
ophthalmologist
\. Patients voluntarily participated in the study with signed informed
consent and agreed to follow up according to the study plan

Exclusion Criteria

History of intraocular surgery or ocular trauma (other than laser iridotomy or laser iriplasty)
Concomitant with other types of glaucoma, including: primary open-angle glaucoma, various types of secondary glaucoma (secondary angle-closure glaucoma, steroidal glaucoma, secondary angle regression glaucoma, neovascular glaucoma, inflammatory secondary glaucoma, true microophthalmia, pseudoextirpation syndrome, etc.)
The International Standardized Ratio (INR) > 3.0 for patients receiving warfarin or anticoagulant therapy before surgery
People with fundus disease that affects the collection of eye parameters or interferes with visual field examination
Long-term local or systemic use of glucocorticoids
Cyclops (corrected visual acuity less than 0.01 in non-study eyes)
Complicated with serious systemic diseases
Pregnant or lactating women
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