Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
NCT ID: NCT04878458
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
124 participants
INTERVENTIONAL
2021-05-31
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEI+GSL+GT
Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy
The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
PEI+Trab
Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.
phacoemulsification with intraocular lens implantation combined with trabeculectomy
The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
40 Years
80 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Harbin Medical University
OTHER
West China Hospital
OTHER
First Hospital of Shijiazhuang City
OTHER
Union hospital of Fujian Medical University
OTHER
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Handan City Eye Hospital
UNKNOWN
Chongqing Medical University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Xiulan Zhang
Director of Clinical Research Center
Principal Investigators
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Xiulan Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Zhongshan Ophthalmic Center
Guangdong, , China
Countries
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References
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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.
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.
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.
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.
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.
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.
Song Y, Li F, Zhang X. Response: Comment on "Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial". Asia Pac J Ophthalmol (Phila). 2024 May-Jun;13(3):100076. doi: 10.1016/j.apjo.2024.100076. Epub 2024 May 23. No abstract available.
Song Y, Lin F, Lv A, Zhang Y, Lu L, Xie L, Tang G, Yuan H, Yang Y, Xu J, Lu P, Xiao M, Zhu X, Yan X, Song W, Li X, Zhang H, Li F, Wang Z, Jin L, Gao X, Liang X, Zhou M, Zhao X, Zhang Y, Chen W, Wang N, Tham CC, Barton K, Park KH, Aung T, Weinreb RN, Tang L, Fan S, Lam DSC, Zhang X; PVP Study group. Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial. Asia Pac J Ophthalmol (Phila). 2024 Jan-Feb;13(1):100033. doi: 10.1016/j.apjo.2023.100033. Epub 2023 Dec 26.
Song Y, Fan S, Tang L, Lin F, Li F, Lv A, Li X, Wen T, Lu L, Xiao M, Xie L, Zhu X, Tang G, Zhang H, Yan X, Yuan H, Song W, Yang Y, Xu J, Zhou F, Wang Z, Jin L, Liang X, Zhou M, Zhao X, Chen W, Park KH, Barton K, Aung T, Tham CC, Lam DSC, Weinreb RN, Wang N, Zhang X; PVP Study Group. Two-Year Outcomes of Phacogoniotomy vs Phacotrabeculectomy for Advanced Primary Angle-Closure Glaucoma With Cataract: A Noninferiority Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jun 1;143(6):462-469. doi: 10.1001/jamaophthalmol.2025.0685.
Song Y, Song W, Zhang Y, Zhang H, Xiao M, Zhao X, Lv A, Yan X, Lu P, Zhu X, Gao X, Hu K, Zhang Y, Liang X, Zhang X, Tang G, Lu L, Zhou M, Fan S, Xie L, Jin L, Tang L, Yuan H, Zhang X; PVP Study group. Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study). BMJ Open. 2021 Dec 8;11(12):e056876. doi: 10.1136/bmjopen-2021-056876.
Other Identifiers
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2021KYPJ090
Identifier Type: -
Identifier Source: org_study_id