Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

NCT05163951 | Recruiting DMC

• 1 other identifier: 2021KYPJ191
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Angle Closure Glaucoma

Keywords

angle closure; glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure at postoperative 12 months

  Intraocular pressure after surgery using Goldmann or non-contact tonometer.

  Postoperative 12 month

Secondary Outcomes (3)

• Cumulative success rate of surgery

  Postoperative 12, 24, 36 months

• Intraoperative and postoperative complications

  Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months

• The numbers of anti-glaucoma medications

  Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months

Other Outcomes (10)

• Visual acuity

  Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months

• The degree of peripheral anterior synechia

  Postoperative 0, 3, 12, 24, 36 months

• Corneal endothelial cell counting

  Postoperative 0,12, 24, 36 months

Study Arms (2)

Trabeculectomy

ACTIVE COMPARATOR

Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.

Procedure: 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).

Procedure: SPI+GSL+GT

Interventions

Trabeculectomy PROCEDURE

trabeculectomy

Trabeculectomy

SPI+GSL+GT PROCEDURE

Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)

SPI+GSL+GT

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45-80 years.
• Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:
• 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);
• Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).
• No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);
• Axial length of ≥20 mm.

You may not qualify if:

• 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.
• Patients with serious systemic diseases.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• 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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 31294768 RESULT

• 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.

  PMID: 31976190 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.

  PMID: 33671386 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.

  PMID: 29613978 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.

  PMID: 33031110 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.

  PMID: 22986111 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.

  PMID: 31727428 RESULT

• 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.

  PMID: 40244579 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.

  PMID: 35788072 DERIVED

MeSH Terms

Conditions

Glaucoma, Angle-Closure; Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Xiulan Zhang, MD. PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiulan Zhang, MD. PhD

CONTACT

+86 13570166308; zhangxl2@mail.sysu.edu.cn

Xinbo Gao, MD. PhD

CONTACT

+86 18319579657; gaoxb@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Center

Model Details: multicenter, parallel, open, non-inferior randomized controlled trial

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 20, 2021
• Study Start: January 5, 2022
• Primary Completion: June 30, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)