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Active, not recruiting Not applicable

Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma

NCT04878458 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2021-05-31
Last updated
2024-12-11

Condition(s) studied

Glaucoma, Angle-Closure

Investigational drug(s) / intervention(s)

phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomyphacoemulsification with intraocular lens implantation combined with trabeculectomy

phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy: The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

phacoemulsification with intraocular lens implantation combined with trabeculectomy: The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Study summary

A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
* Inclusion criteria 1. Aged 40-80 years; 2. Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4) 1. At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes; 2. IOP \>21 mmHg with or without anti-glaucoma medication; 3. Obvious glaucomatous optic neuropathy (cup-to-disc \[C/D\] ratio≥0.7, or C/D asymmetry \> 0.2, or the rim width at the superior and inferior temporal \< 0.1 vertical diameters of optic disc); 4. With glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer using SITA-Standard 24-2 or 30-2 algorithm; mean deviation ≤ -12dB; 3. Clinically obvious cataract and uncorrected visual acuity (UCVA) \<0.63 (Early Treatment Diabetic Retinopathy Study, \[ETDRS\] chart), or need lens extraction assessed by a clinician; 4. Voluntarily participate in study and provide signed informed consent. * Exclusion criteria a. History of ocular surgery (other than laser iridotomy or laser iriplasty) or trauma; b. With other types of glaucoma; (i.e. open angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle regression glaucoma, neovascular glaucoma, nanophthalmos, pseudoexfoliation syndrome) c. The International Standardized Ratio \> 3.0 for patients receiving warfarin or anticoagulant therapy before surgery; d. With retinal disease that affects the collection of ocular parameters; f. Monophthalmia (best-corrected visual acuity \[BCVA\] \<0.01 in the non-study eye); g. With other serious systemic diseases; h. Pregnant or lactating women \* If both eyes are eligible for the study, the eye with the worse UCVA will be recruited.

Primary outcome measure(s)

  • Mean change of intraocular pressure — Postoperative 12, 24, 36 months.
    Change from baseline IOP after surgery using Goldmann or non-contact tonometer.

Trial sites (2)

FacilityCityRegionStatus
Zhongshan Ophthalmic Center Guangzhou Guangdong
Zhongshan Ophthalmic Center Guangdong China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04878458 on ClinicalTrials.gov ↗ ← All trials in China