An interventional study of phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy and phacoemulsification with intraocular lens implantation combined with trabeculectomy in Glaucoma, Angle-Closure, sponsored by Sun Yat-sen University. Active, not recruiting at 2 sites in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method is anti-glaucoma surgery-trabeculectomy (Trab) combined with lens extraction. Phacotrabeculectomy has become the first-line choice of anti-glaucoma suregery in the treatment of advanced PACG. However, it was not an ideal method due to the bleb-related complications and troublesome postoperative nursing, as well as the difficulty for surgeons, caused by trabeculectomy. However, recent studies revealed that the phacoemulsification with intraocular lens implantation (PEI) combined with goniosynechialysis (GSL) has achieved efficacy in the treatment of PACG.
With the advent of minimally invasive glaucoma surgeries (MIGS), there is an increasing number studies indicating the MIGS performed great efficacy in the treatment of primary open angle glaucoma. While,there were a few small-sampled retrospective studies which showed therapeutic effects in PACG. The GSL plus goniotomy (GT) could achieve great efficacy in lowering the intraocular pressure of PACG patients. However, there is still a lack of high quality and high-level randomized controlled trials.
Therefore, this study intends to conduct a multicenter, parallel, open, non-inferior randomized controlled trial to compare the effectiveness and safety of PEI+ Trab and PEI+GSL+GT in the treatment of advanced PACG, so as to provide a better surgical treatment for PACG.
91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.
This study's enrollment of 124 is above the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.
Browse Glaucoma, Angle-Closure studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
Procedure: phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy
Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.
Procedure: phacoemulsification with intraocular lens implantation combined with trabeculectomy
The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.
Mean change of intraocular pressure
Change from baseline IOP after surgery using Goldmann or non-contact tonometer.
Time frame: Postoperative 12, 24, 36 months.
Cumulative success rate of surgery
(i) Complete success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with no need for IOP-lowering medication. (ii) Qualified success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with or without IOP-lowering medication.
Time frame: 12, 24, 36 months
Intraoperative and postoperative complications
For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.
Time frame: 0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Anti-glaucomatous medications
Numbers and types of anti-glaucomatous medications
Time frame: 0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Visual acuity
Uncorrected and best corrected visual acuity will be documented using ETDRS chart.
Time frame: 0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Degree of peripheral anterior synechia
The peripheral anterior synechia is checked using gonioscopy.
Time frame: 3, 12, 24, 36 months
Corneal endothelial cell counting
Corneal endothelial cell counting will be documented using specular microscope.
Time frame: 0, 12, 24, 36 months
Visual field
Visual field examination is performed using Humphrey analyzer.
Time frame: 0, 12, 24, 36 months
Optic nerve head morphology and retinal parameters
Optic nerve head morphology and retinal parameters based on optical coherence tomography (Cirrus 5000, Zeiss, CA, USA or Spectralis, Heidelberg, Germany)
Time frame: 0, 12, 24, 36 months
Measurement of quality of life
Quality of life is measured with EQ-5D-5L questionnaire.
Time frame: 0, 12, 24, 36 months
Filtering bleb classification
Filtering bleb classification based on Indiana Bleb Appearance Grading Scale
Time frame: 12, 24, 36 months
Time-consuming of operation and the surgery cost
Time-consuming of operation and the surgery cost are based on the electronic healthy system.
Time frame: 1 day
Plan to share: No
Ran from May 2021 to primary completion in May 2023, 23 months.
Of 28 interventional studies with no phase under Glaucoma, Angle-Closure, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 43. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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