Active, not recruiting
Not applicable
Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
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
* 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)
| Facility | City | Region | Status |
| Zhongshan Ophthalmic Center |
Guangzhou |
Guangdong |
|
| Zhongshan Ophthalmic Center |
Guangdong |
China |
|
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