Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma

NCT04878458 | Active Not Recruiting DMC

• 1 other identifier: 2021KYPJ090
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief Summary

A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.

Conditions

Glaucoma, Angle-Closure

Keywords

Glaucoma, Angle-Closure

Outcome Measures

Primary Outcomes (1)

• Mean change of intraocular pressure

  Change from baseline IOP after surgery using Goldmann or non-contact tonometer.

  Postoperative 12, 24, 36 months.

Secondary Outcomes (3)

• Cumulative success rate of surgery

  12, 24, 36 months

• Intraoperative and postoperative complications

  0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months

• Anti-glaucomatous medications

  0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months

Other Outcomes (8)

• Visual acuity

  0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months

• Degree of peripheral anterior synechia

  3, 12, 24, 36 months

• Corneal endothelial cell counting

  0, 12, 24, 36 months

Study Arms (2)

PEI+GSL+GT

EXPERIMENTAL

Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

Procedure: phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy

PEI+Trab

EXPERIMENTAL

Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Procedure: phacoemulsification with intraocular lens implantation combined with trabeculectomy

Interventions

phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy PROCEDURE

The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

PEI+GSL+GT

phacoemulsification with intraocular lens implantation combined with trabeculectomy PROCEDURE

The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.

PEI+Trab

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 40-80 years;
• Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)
• At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes;
• IOP \>21 mmHg with or without anti-glaucoma medication;
• 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);
• 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;
• 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;
• Voluntarily participate in study and provide signed informed consent.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The Second Affiliated Hospital of Harbin Medical University: collaborator
• West China Hospital: collaborator
• First Hospital of Shijiazhuang City: collaborator
• Union hospital of Fujian Medical University: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Handan City Eye Hospital: collaborator
• Chongqing Medical University: collaborator

Study Sites (2)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location

Zhongshan Ophthalmic Center

Guangdong, China

Location

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 38795868 RESULT

• 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.

  PMID: 38383075 RESULT

• 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.

  PMID: 40244620 DERIVED

• 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.

  PMID: 34880029 DERIVED

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Phacoemulsification; Trabeculectomy

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Filtering Surgery

Study Officials

• Xiulan Zhang, MD, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

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: May 6, 2021
• First Posted: May 7, 2021
• Study Start: May 31, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)