Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG (TVG)

• ClinicalTrials.gov Identifier: NCT05163951
• Recruitment Status: Recruiting
• First Posted: December 20, 2021
• Last Update Posted: June 14, 2022
• Sponsor: Sun Yat-sen University
• Collaborators: The Second Affiliated Hospital of Harbin Medical University; First Hospital of Shijiazhuang City; West China Hospital; The Third Affiliated Hospital of Chongqing Medical University; Handan City Eye Hospital; People's Hospital of Chongqing
• Information provided by (Responsible Party): Xiulan Zhang, Sun Yat-sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Primary Angle Closure Glaucoma	Procedure: Trabeculectomy; Procedure: SPI+GSL+GT	Not Applicable

Detailed Description:

Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: multicenter, parallel, open, non-inferior randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial
• Actual Study Start Date: January 5, 2022
• Estimated Primary Completion Date: June 30, 2024
• Estimated Study Completion Date: June 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Trabeculectomy; Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.	Procedure: Trabeculectomy; trabeculectomy
Experimental: 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).	Procedure: SPI+GSL+GT; Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)

Outcome Measures

Primary Outcome Measures :

1. Intraocular pressure at postoperative 12 months [ Time Frame: Postoperative 12 month ]
   Intraocular pressure after surgery using Goldmann or non-contact tonometer.

Secondary Outcome Measures :

1. Cumulative success rate of surgery [ Time Frame: Postoperative 12, 24, 36 months ]

   Cumulative success rate of surgery is defined as :

   (i) Complete success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline without anti-glaucoma medications.

   (ii) Qualified success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline with anti-glaucoma medications.

2. Intraoperative and postoperative complications [ Time Frame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months ]
   Intraoperative and postoperative complications, such as shallow anterior chamber, malignant glaucoma, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and bleb-related complications.
3. The numbers of anti-glaucoma medications [ Time Frame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months ]
   Numbers of anti-glaucoma medications.

Other Outcome Measures:

1. Visual acuity [ Time Frame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months ]
   Uncorrected and best corrected visual acuity will be documented using ETDRS chart.
2. The degree of peripheral anterior synechia [ Time Frame: Postoperative 0, 3, 12, 24, 36 months ]
   The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented.
3. Corneal endothelial cell counting [ Time Frame: Postoperative 0,12, 24, 36 months ]
   Corneal endothelial cell counting will be documented using specular microscope.
4. Visual field [ Time Frame: Postoperative 0,6,12, 24, 36 months ]
   Visual field will be performed using Humphrey analyzer, in which parameters of mean deviation (MD), pattern standard deviation (PSD) will be documented.
5. Optic nerve head morphology [ Time Frame: Postoperative 0,12, 24, 36 months ]
   Optic nerve head morphology will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany).
6. Retinal thickness [ Time Frame: Postoperative 0,12, 24, 36 months ]
   Retinal thickness will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany).
7. The quality of life [ Time Frame: Postoperative 0,12, 24, 36 months ]
   Quality of life will be measured with EQ-5D-5L questionnaire.
8. Filtering bleb classification [ Time Frame: Postoperative 3, 12, 24, 36 months ]
   Filtering bleb classification using the Indiana Bleb Appearance Grading Scale, including height, width, extent, vascularity, and Seidel test.
9. Surgical time [ Time Frame: Postoperative 1 day ]
   Surgical time will be documented.
10. Surgical cost [ Time Frame: Postoperative 1 day ]
    Surgical cost will be documented.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age 45-80 years.

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:

1. History of ocular surgery or trauma.
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.

Contacts and Locations

Contacts

Contact: Xiulan Zhang, MD. PhD; +86 13570166308; zhangxl2@mail.sysu.edu.cn

Contact: Xinbo Gao, MD. PhD; +86 18319579657; gaoxb@mail.sysu.edu.cn

Locations

China, Guangdong

Zhongshan Ophthalmic Center, Sun Yat-sen University; Recruiting

Guangzhou, Guangdong, China, 510060

Contact: Xiulan Zhang, MD, PhD +86 13059106657 zhangxl2@mail.sysu.edu.cn

Contact: Xinbo Gao, MD, PhD +86 18319579657 gaoxb@mail.sysu.edu.cn

Sponsors and Collaborators

Sun Yat-sen University

The Second Affiliated Hospital of Harbin Medical University

First Hospital of Shijiazhuang City

West China Hospital

The Third Affiliated Hospital of Chongqing Medical University

Handan City Eye Hospital

People's Hospital of Chongqing

Investigators

• Principal Investigator: Xiulan Zhang, MD. PhD; Zhongshan Ophthalmic Center, Sun Yat-sen University

More Information

Publications of Results:

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). pii: 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Xiulan Zhang, Director of Clinical Research Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05163951
• Other Study ID Numbers: 2021KYPJ191
• First Posted: December 20, 2021
• Last Update Posted: June 14, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiulan Zhang, Sun Yat-sen University:

angle closure; glaucoma

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Angle-Closure; Ocular Hypertension; Eye Diseases