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

Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Glaucoma, Angle-Closure
• Intervention / Treatment: Procedure: phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy; Procedure: phacoemulsification with intraocular lens implantation combined with trabeculectomy

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method is anti-glaucoma surgery-trabeculectomy (Trab) combined with lens extraction. Phacotrabeculectomy has become the first-line choice of anti-glaucoma suregery in the treatment of advanced PACG. However, it was not an ideal method due to the bleb-related complications and troublesome postoperative nursing, as well as the difficulty for surgeons, caused by trabeculectomy. However, recent studies revealed that the phacoemulsification with intraocular lens implantation (PEI) combined with goniosynechialysis (GSL) has achieved efficacy in the treatment of PACG.

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.

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong, China
    • Zhongshan Ophthalmic Center
  • Guangdong
    • Guangzhou, Guangdong, China
      • Zhongshan Ophthalmic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• Inclusion criteria

  1. Aged 40-80 years;

  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.
• Exclusion criteria a. History of ocular surgery (other than laser iridotomy or laser iriplasty) or trauma; b. With other types of glaucoma; (i.e. open angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle regression glaucoma, neovascular glaucoma, nanophthalmos, pseudoexfoliation syndrome) c. The International Standardized Ratio > 3.0 for patients receiving warfarin or anticoagulant therapy before surgery; d. With retinal disease that affects the collection of ocular parameters; f. Monophthalmia (best-corrected visual acuity [BCVA] <0.01 in the non-study eye); g. With other serious systemic diseases; h. Pregnant or lactating women * If both eyes are eligible for the study, the eye with the worse UCVA will be recruited.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEI+GSL+GT; 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; The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
Experimental: PEI+Trab; 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; The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of intraocular pressure	Change from baseline IOP after surgery using Goldmann or non-contact tonometer.	Postoperative 12, 24, 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative success rate of surgery	(i) Complete success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with no need for IOP-lowering medication. (ii) Qualified success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with or without IOP-lowering medication.	12, 24, 36 months
Intraoperative and postoperative complications	For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Anti-glaucomatous medications	Numbers and types of anti-glaucomatous medications	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Uncorrected and best corrected visual acuity will be documented using ETDRS chart.	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Degree of peripheral anterior synechia	The peripheral anterior synechia is checked using gonioscopy.	3, 12, 24, 36 months
Corneal endothelial cell counting	Corneal endothelial cell counting will be documented using specular microscope.	0, 12, 24, 36 months
Visual field	Visual field examination is performed using Humphrey analyzer.	0, 12, 24, 36 months
Optic nerve head morphology and retinal parameters	Optic nerve head morphology and retinal parameters based on optical coherence tomography (Cirrus 5000, Zeiss, CA, USA or Spectralis, Heidelberg, Germany)	0, 12, 24, 36 months
Measurement of quality of life	Quality of life is measured with EQ-5D-5L questionnaire.	0, 12, 24, 36 months
Filtering bleb classification	Filtering bleb classification based on Indiana Bleb Appearance Grading Scale	12, 24, 36 months
Time-consuming of operation and the surgery cost	Time-consuming of operation and the surgery cost are based on the electronic healthy system.	1 day

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: West China Hospital; Chongqing Medical University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; The Second Affiliated Hospital of Harbin Medical University; First Hospital of Shijiazhuang City; Union hospital of Fujian Medical University; Handan City Eye Hospital
• Investigators: Principal Investigator: Xiulan Zhang, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.
• 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.
• 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, 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Glaucoma, Angle-Closure
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: 2021KYPJ090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No