Comparing two surgical methods for advanced primary angle closure glaucoma

Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial

This study is testing which surgical method, trabeculectomy or a combination of two other procedures, works better and is safer for people with advanced primary angle closure glaucoma who have no or mild cataracts.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 88 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05163951 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness and safety of trabeculectomy versus a combination of peripheral iridectomy and goniotomy in patients with advanced primary angle closure glaucoma who have no or mild cataracts. It is a multicenter, open-label, randomized controlled trial designed to assess which surgical approach provides better outcomes for this condition. The study will evaluate various parameters including intraocular pressure, visual acuity, and complications associated with each surgical method. By exploring these two treatment options, the trial seeks to identify a safer and more effective intervention for patients at risk of complications from traditional surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 45-80 years diagnosed with advanced primary angle closure glaucoma and no or mild cataracts.

Not a fit: Patients with a history of ocular surgery or trauma, or those with significant retinal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer surgical option for patients with advanced primary angle closure glaucoma, potentially reducing the risk of complications.

How similar studies have performed: Other studies have shown success with similar minimally invasive approaches, indicating potential for positive outcomes in this trial.

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.

Where this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Xiulan Zhang, MD. PhD — Zhongshan Ophthalmic Center, Sun Yat-sen University
• Study coordinator: Xiulan Zhang, MD. PhD

Conditions: Primary Angle Closure Glaucoma, angle closure, glaucoma