TVG
Trial question
Is peripheral iridectomy with goniosynechialysis and goniotomy noninferior to trabeculectomy in patients with advanced primary angle-closure glaucoma without cataract?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
59.0% female
41.0% male
N = 88
88 patients (52 female, 36 male).
Inclusion criteria: patients with advanced primary angle-closure glaucoma without cataract.
Key exclusion criteria: history of ocular surgery or trauma; retinal disease that would influence the collection of ocular parameters or other types of glaucoma; monophthalmia; INR of > 3.0 for patients receiving warfarin or anticoagulant therapy before surgery; serious systemic disease; pregnancy or lactation.
Interventions
N=43 SPI+GSL+GT (combination of surgical peripheral iridectomy with goniosynechialysis and goniotomy).
N=45 trabeculectomy (trabeculectomy alone).
Primary outcome
Intraocular pressure at 12 months after surgery
15.6 mmHg
14.9 mmHg
15.6 mmHg
11.7 mmHg
7.8 mmHg
3.9 mmHg
0.0 mmHg
SPI+GSL+GT
Trabeculectomy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in intraocular pressure at 12 months after surgery (15.6 mmHg vs. 14.9 mmHg; AD 0.5 mmHg, 95% CI -1.2 to 2.2).
Secondary outcomes
No significant difference in qualified surgical success at 12 months (88.4% vs. 93.3%; ARD -5, 95% CI -19.6 to 8.5).
No significant difference in postoperative complications (18.6% vs. 20%; ARD -1.4, 95% CI -17.9 to 15.1).
Significant decrease in postoperative interventions (7% vs. 55.6%; ARD -48.6, 95% CI -65 to -32.2).
Safety outcomes
No significant differences in best-corrected visual acuity, endothelial cell density.
Conclusion
In patients with advanced primary angle-closure glaucoma without cataract, SPI+GSL+GT was noninferior to trabeculectomy with respect to intraocular pressure at 12 months after surgery.
Reference
Fengbin Lin, Aiguo Lv, Fei Li et al. Peripheral Iridectomy With Goniosynechialysis and Goniotomy vs Trabeculectomy for Advanced PACG: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 17. Online ahead of print.
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