Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
NCT ID: NCT05163951
Last Updated: 2022-06-14
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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RECRUITING
NA
88 participants
INTERVENTIONAL
2022-01-05
2026-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trabeculectomy
Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.
Trabeculectomy
trabeculectomy
SPI+GSL+GT
Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT).
SPI+GSL+GT
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)
Interventions
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Trabeculectomy
trabeculectomy
SPI+GSL+GT
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
80 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Harbin Medical University
OTHER
First Hospital of Shijiazhuang City
OTHER
West China Hospital
OTHER
Chongqing Medical University
OTHER
Handan City Eye Hospital
UNKNOWN
People's Hospital of Chongqing
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, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
Other Identifiers
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2021KYPJ191
Identifier Type: -
Identifier Source: org_study_id
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