Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG (TVG)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    88
  • sponsor
    Sun Yat-sen University
Updated on 30 June 2022

Summary

A multicenter, parallel, open, non-inferior randomized controlled trial is conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma with no or mild cataracts.

Description

Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative.

Minimally invasive glaucoma surgery (MIGS) has recently showed its safety and effectiveness in the treatment of PACG, usually combined with cataract surgery, goniosynechialysis (GSL) and goniotomy(GT). The safety and effectiveness of phacoemulsification and intraocular lens implantation (PEI)+GSL+GT in advanced PACG with cataract has been conducted (clinical trials.gov, NCT04878458). It is valuable to explore the safety and efficacy of SPI+GSL+GT in these PACG patients with no or mild cataracts.

Therefore, this study intends to conduct a multicenter, non-inferior randomized controlled clinical trial to compare the effectiveness and safety of trabeculectomy versus SPI+GSL+GT in advanced PACG with no or mild cataracts.

Details
Condition Primary Angle Closure Glaucoma
Treatment trabeculectomy, SPI+GSL+GT
Clinical Study IdentifierNCT05163951
SponsorSun Yat-sen University
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 45-80 years
Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d
PAS: ≥180° range, including nasal and inferior quadrants
IOP >21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer
Glaucomatous optic neuropathy (cup-to-disc [C/D] ratio ≥0.7, C/D asymmetry >0.2, or rim width at the superior and inferior temporal areas <0.1 of the vertical diameters of the optic disc)
Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB)
No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic
Retinopathy Study chart)
Axial length of ≥20 mm

Exclusion Criteria

History of ocular surgery or trauma
Retinal disease that influences the collection of ocular parameters or other types of glaucoma, including open-angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle recession glaucoma, neovascular glaucoma, nanophthalmos, and pseudoexfoliation syndrome
Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye)
Pregnant or lactating women
An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery
Patients with serious systemic diseases
If both eyes are eligible for the study, the eye with the worse visual field or optic nerve
will be included
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