Primary Angle Closure Glaucoma
Conditions
Keywords
angle closure, glaucoma
Brief 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.
Detailed 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.
Interventions
PROCEDURETrabeculectomy
trabeculectomy
PROCEDURESPI+GSL+GT
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)
Sponsors
The Second Affiliated Hospital of Harbin Medical University
First Hospital of Shijiazhuang City
West China Hospital
Chongqing Medical University
Handan City Eye Hospital
People's Hospital of Chongqing
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multicenter, parallel, open, non-inferior randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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: 1. PAS: ≥180° range, including nasal and inferior quadrants; 2. IOP \>21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer; 3. 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); 4. Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB). 3. No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart); 4. Axial length of ≥20 mm.
Exclusion criteria
1. History of ocular surgery or trauma. 2. 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. 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 or anticoagulant 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 nerve will be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure at postoperative 12 months | Postoperative 12 month | Intraocular pressure after surgery using Goldmann or non-contact tonometer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative success rate of surgery | Postoperative 12, 24, 36 months | 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. |
| Intraoperative and postoperative complications | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months | Intraoperative and postoperative complications, such as shallow anterior chamber, malignant glaucoma, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and bleb-related complications. |
| The numbers of anti-glaucoma medications | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months | Numbers of anti-glaucoma medications. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Optic nerve head morphology | Postoperative 0,12, 24, 36 months | Optic nerve head morphology will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany). |
| Retinal thickness | Postoperative 0,12, 24, 36 months | Retinal thickness will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany). |
| The quality of life | Postoperative 0,12, 24, 36 months | Quality of life will be measured with EQ-5D-5L questionnaire. |
| Visual acuity | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months | Uncorrected and best corrected visual acuity will be documented using ETDRS chart. |
| Surgical time | Postoperative 1 day | Surgical time will be documented. |
| Surgical cost | Postoperative 1 day | Surgical cost will be documented. |
| Filtering bleb classification | Postoperative 3, 12, 24, 36 months | Filtering bleb classification using the Indiana Bleb Appearance Grading Scale, including height, width, extent, vascularity, and Seidel test. |
| The degree of peripheral anterior synechia | Postoperative 0, 3, 12, 24, 36 months | The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented. |
| Corneal endothelial cell counting | Postoperative 0,12, 24, 36 months | Corneal endothelial cell counting will be documented using specular microscope. |
| Visual field | Postoperative 0,6,12, 24, 36 months | Visual field will be performed using Humphrey analyzer, in which parameters of mean deviation (MD), pattern standard deviation (PSD) will be documented. |
Countries
China
Contacts
Primary ContactXiulan Zhang, MD. PhD
Backup ContactXinbo Gao, MD. PhD
Outcome results
None listed