Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
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.
| Condition(s) | Primary Angle Closure Glaucoma |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Age 45-80 years. 2. Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d: 1. PAS: ≥180° range, including nasal and inferior quadrants; 2. IOP \>21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer; 3. 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); 4. Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB). 3. No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Dia |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Lead sponsor | Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2022-01-05 |
| NCT ID | NCT05163951 |
| Official listing | https://clinicaltrials.gov/study/NCT05163951 |