Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

Launched by SUN YAT-SEN UNIVERSITY · Dec 4, 2021

Keywords

ClinConnect Summary

This clinical trial is comparing two surgical procedures to find out which one is more effective and safer for treating advanced primary angle closure glaucoma (PACG). The two procedures being studied are trabeculectomy and a combination of peripheral iridectomy plus goniotomy (referred to as TVG). The goal is to help patients with advanced PACG who have no or mild cataracts, and the trial is currently looking for participants aged 45 to 80.

To be eligible for the study, participants must have specific signs of advanced PACG, such as high eye pressure and certain types of visual field loss. They should have no or mild cataracts and decent vision without correction. If you join the study, you’ll receive one of the two treatments, and the doctors will monitor your progress closely. It’s important to note that certain conditions, like previous eye surgeries or serious health problems, may prevent someone from participating. This trial will provide valuable information that could help improve treatments for PACG in the future.

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Eligibility criteria

• 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 Diabetic Retinopathy Study chart);
• • 4. Axial length of ≥20 mm.
• Exclusion Criteria:
• • 1. History of ocular surgery or trauma.
• • 2. 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.
• • 3. Monophthalmia (best-corrected visual acuity of \<0.01 in the non-study eye).
• • 4. An International Standardized Ratio of \>3.0, for patients receiving warfarin or anticoagulant therapy before surgery.
• • 5. Patients with serious systemic diseases.
• • 6. Pregnant or lactating women.
• • If both eyes are eligible for the study, the eye with the worse visual field or optic nerve will be included.