Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
ConditionPrimary Angle Closure Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorSun Yat-sen University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 45-80 years.
PAS: ≥180° range, including nasal and inferior quadrants;
IOP >21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer;
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);
Disqualifiers
History of ocular surgery or trauma.
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.
Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye).
An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery.
Trial design
Design model
Parallel
Treatments tested in this trial
Trabeculectomy
Procedure/Surgerytrabeculectomy
SPI+GSL+GT
Procedure/SurgeryPeripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: TrabeculectomyActive comparator 1 intervention
Group B: SPI+GSL+GTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Intraocular pressure at postoperative 12 months
Intraocular pressure after surgery using Goldmann or non-contact tonometer.
Time frame
Postoperative 12 monthSecondary outcomes
1
Cumulative success rate of surgery
Cumulative success rate of surgery is defined as : (i) Complete success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline without anti-glaucoma medications. (ii) Qualified success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline with anti-glaucoma medications.
Time frame
Postoperative 12, 24, 36 months2
Intraoperative and postoperative complications
Intraoperative and postoperative complications, such as shallow anterior chamber, malignant glaucoma, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and bleb-related complications.
Time frame
Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months3
The numbers of anti-glaucoma medications
Numbers of anti-glaucoma medications.
Time frame
Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 monthsOther outcomes
1
Visual acuity
Uncorrected and best corrected visual acuity will be documented using ETDRS chart.
Time frame
Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months2
The degree of peripheral anterior synechia
The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented.
Time frame
Postoperative 0, 3, 12, 24, 36 months3
Corneal endothelial cell counting
Corneal endothelial cell counting will be documented using specular microscope.
Time frame
Postoperative 0,12, 24, 36 months4
Visual field
Visual field will be performed using Humphrey analyzer, in which parameters of mean deviation (MD), pattern standard deviation (PSD) will be documented.
Time frame
Postoperative 0,6,12, 24, 36 monthsSponsors and contacts
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Sun Yat-sen University
Lead sponsor
The Second Affiliated Hospital of Harbin Medical University
Collaborator
First Hospital of Shijiazhuang City
Collaborator
West China Hospital
Collaborator
Chongqing Medical University
Collaborator
Handan City Eye Hospital
Collaborator
People's Hospital of Chongqing
Collaborator
Source ClinicalTrials.gov