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| Name | Class |
|---|---|
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| First Hospital of Shijiazhuang City | OTHER |
| West China Hospital | OTHER |
| Chongqing Medical University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabeculectomy | Active Comparator | Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy. |
|
| SPI+GSL+GT | Experimental | Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabeculectomy | Procedure | trabeculectomy |
| |
| SPI+GSL+GT |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure at postoperative 12 months | Intraocular pressure after surgery using Goldmann or non-contact tonometer. | Postoperative 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Uncorrected and best corrected visual acuity will be documented using ETDRS chart. | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months |
| The degree of peripheral anterior synechia |
Inclusion Criteria:
Age 45-80 years.
Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:
No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);
Axial length of ≥20 mm.
Exclusion Criteria:
If both eyes are eligible for the study, the eye with the worse visual field or optic nerve will be included.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiulan Zhang, MD. PhD | Contact | +86 13570166308 | zhangxl2@mail.sysu.edu.cn | |
| Xinbo Gao, MD. PhD | Contact | +86 18319579657 | gaoxb@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiulan Zhang, MD. PhD | Zhongshan Ophthalmic Center, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31294768 | Result | Husain R, Do T, Lai J, Kitnarong N, Nongpiur ME, Perera SA, Ho CL, Lim SK, Aung T. Efficacy of Phacoemulsification Alone vs Phacoemulsification With Goniosynechialysis in Patients With Primary Angle-Closure Disease: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Oct 1;137(10):1107-1113. doi: 10.1001/jamaophthalmol.2019.2493. | |
| 31976190 |
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| ID | Term |
|---|---|
| D015812 | Glaucoma, Angle-Closure |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| Handan City Eye Hospital | UNKNOWN |
| People's Hospital of Chongqing | OTHER |
multicenter, parallel, open, non-inferior randomized controlled trial
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| Procedure |
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT) |
|
| Postoperative 12, 24, 36 months |
| 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. | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months |
| The numbers of anti-glaucoma medications | Numbers of anti-glaucoma medications. | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months |
The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented.
| Postoperative 0, 3, 12, 24, 36 months |
| Corneal endothelial cell counting | Corneal endothelial cell counting will be documented using specular microscope. | Postoperative 0,12, 24, 36 months |
| Visual field | Visual field will be performed using Humphrey analyzer, in which parameters of mean deviation (MD), pattern standard deviation (PSD) will be documented. | Postoperative 0,6,12, 24, 36 months |
| Optic nerve head morphology | Optic nerve head morphology will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany). | Postoperative 0,12, 24, 36 months |
| Retinal thickness | Retinal thickness will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany). | Postoperative 0,12, 24, 36 months |
| The quality of life | Quality of life will be measured with EQ-5D-5L questionnaire. | Postoperative 0,12, 24, 36 months |
| Filtering bleb classification | Filtering bleb classification using the Indiana Bleb Appearance Grading Scale, including height, width, extent, vascularity, and Seidel test. | Postoperative 3, 12, 24, 36 months |
| Surgical time | Surgical time will be documented. | Postoperative 1 day |
| Surgical cost | Surgical cost will be documented. | Postoperative 1 day |
| Barry M, Alahmadi MW, Alahmadi M, AlMuzaini A, AlMohammadi M. The Safety of the Kahook Dual Blade in the Surgical Treatment of Glaucoma. Cureus. 2020 Jan 16;12(1):e6682. doi: 10.7759/cureus.6682. |
| 33671386 | Result | Tanito M, Sugihara K, Tsutsui A, Hara K, Manabe K, Matsuoka Y. Midterm Results of Microhook ab Interno Trabeculotomy in Initial 560 Eyes with Glaucoma. J Clin Med. 2021 Feb 17;10(4):814. doi: 10.3390/jcm10040814. |
| 29613978 | Result | Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956. |
| 33031110 | Result | Dorairaj S, Tam MD, Balasubramani GK. Two-Year Clinical Outcomes of Combined Phacoemulsification, Goniosynechialysis, and Excisional Goniotomy For Angle-Closure Glaucoma. Asia Pac J Ophthalmol (Phila). 2020 Oct 6;10(2):183-187. doi: 10.1097/APO.0000000000000321. |
| 22986111 | Result | Tham CC, Kwong YY, Baig N, Leung DY, Li FC, Lam DS. Phacoemulsification versus trabeculectomy in medically uncontrolled chronic angle-closure glaucoma without cataract. Ophthalmology. 2013 Jan;120(1):62-7. doi: 10.1016/j.ophtha.2012.07.021. Epub 2012 Sep 15. |
| 31727428 | Result | Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9. |
| 40244579 | Derived | Lin F, Lv A, Li F, Song Y, Xie L, Zhu X, Tang L, Zhang Y, Huang J, Tang G, Zhang H, Lu L, Xiao M, Xu J, Nie X, Liao M, Yang Y, Gao K, Yuan H, Song W, Zuo C, Lu P, Yan X, Zhou F, Wang Z, Jin L, Peng Y, Chen W, Barton K, Park KH, Aung T, Lam DSC, Weinreb RN, Wang N, Tham CC, Fan S, Zhang X; TVG study group. Peripheral Iridectomy With Goniosynechialysis and Goniotomy vs Trabeculectomy for Advanced PACG: A Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jun 1;143(6):472-479. doi: 10.1001/jamaophthalmol.2025.0757. |
| 35788072 | Derived | Gao X, Lv A, Lin F, Lu P, Zhang Y, Song W, Zhu X, Zhang H, Liao M, Song Y, Hu K, Zhang Y, Peng Y, Tang L, Yuan H, Xie L, Tang G, Nie X, Jin L, Fan S, Zhang X; TVG study group. Efficacy and safety of trabeculectomy versus peripheral iridectomy plus goniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre, non-inferiority, randomised controlled trial (the TVG study). BMJ Open. 2022 Jul 4;12(7):e062441. doi: 10.1136/bmjopen-2022-062441. |