Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

Last updated: June 9, 2022
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

N/A

Clinical Study ID

NCT05163951
2021KYPJ191
  • Ages 45-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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:
  3. PAS: ≥180° range, including nasal and inferior quadrants;
  4. IOP >21 mmHg with or without anti-glaucoma medications (the medications includethe maximally tolerated medications), taken with the Goldmann applanationtonometer;
  5. 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 verticaldiameters of the optic disc);
  6. Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentralscotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).
  7. No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment DiabeticRetinopathy Study chart);
  8. Axial length of ≥20 mm.

Exclusion

Exclusion Criteria:

  1. History of ocular surgery or trauma.
  2. Retinal disease that influences the collection of ocular parameters or other types ofglaucoma, including open-angle glaucoma, secondary angle-closure glaucoma, steroidalglaucoma, angle recession glaucoma, neovascular glaucoma, nanophthalmos, andpseudoexfoliation 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 oranticoagulant 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 nervewill be included.

Study Design

Total Participants: 88
Study Start date:
January 05, 2022
Estimated Completion Date:
June 30, 2026

Study Description

Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative.

Minimally invasive glaucoma surgery (MIGS) has recently showed its safety and effectiveness in the treatment of PACG, usually combined with cataract surgery, goniosynechialysis (GSL) and goniotomy(GT). The safety and effectiveness of phacoemulsification and intraocular lens implantation (PEI)+GSL+GT in advanced PACG with cataract has been conducted (clinical trials.gov, NCT04878458). It is valuable to explore the safety and efficacy of SPI+GSL+GT in these PACG patients with no or mild cataracts.

Therefore, this study intends to conduct a multicenter, non-inferior randomized controlled clinical trial to compare the effectiveness and safety of trabeculectomy versus SPI+GSL+GT in advanced PACG with no or mild cataracts.

Connect with a study center

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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