Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG (NCT05163951) | Clinical Trial Compass
RecruitingNot Applicable
Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
China88 participantsStarted 2022-01-05
Plain-language 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
Age range45 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).