Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

Primary Angle Closure Glaucoma Clinical Trial

— TVG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163951
• Other study ID #: 2021KYPJ191
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2022
• Source: Sun Yat-sen University
• Contact: Xiulan Zhang, MD. PhD
• Phone: +86 13570166308
• Email: zhangxl2[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure
• Primary Angle Closure Glaucoma

Intervention

Procedure:
• Trabeculectomy
trabeculectomy
• SPI+GSL+GT
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Sun Yat-sen University	First Hospital of Shijiazhuang City, Handan City Eye Hospital, People's Hospital of Chongqing, The Second Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Chongqing Medical University, West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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.0000000000 — View Citation

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 — View Citation

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.00000000 — View Citation

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 Ophth — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual acuity	Uncorrected and best corrected visual acuity will be documented using ETDRS chart.	Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
Other	The degree of peripheral anterior synechia	The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented.	Postoperative 0, 3, 12, 24, 36 months
Other	Corneal endothelial cell counting	Corneal endothelial cell counting will be documented using specular microscope.	Postoperative 0,12, 24, 36 months
Other	Visual field	Visual field will be performed using Humphrey analyzer, in which parameters of mean deviation (MD), pattern standard deviation (PSD) will be documented.	Postoperative 0,6,12, 24, 36 months
Other	Optic nerve head morphology	Optic nerve head morphology will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany).	Postoperative 0,12, 24, 36 months
Other	Retinal thickness	Retinal thickness will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany).	Postoperative 0,12, 24, 36 months
Other	The quality of life	Quality of life will be measured with EQ-5D-5L questionnaire.	Postoperative 0,12, 24, 36 months
Other	Filtering bleb classification	Filtering bleb classification using the Indiana Bleb Appearance Grading Scale, including height, width, extent, vascularity, and Seidel test.	Postoperative 3, 12, 24, 36 months
Other	Surgical time	Surgical time will be documented.	Postoperative 1 day
Other	Surgical cost	Surgical cost will be documented.	Postoperative 1 day
Primary	Intraocular pressure at postoperative 12 months	Intraocular pressure after surgery using Goldmann or non-contact tonometer.	Postoperative 12 month
Secondary	Cumulative success rate of surgery	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.	Postoperative 12, 24, 36 months
Secondary	Intraoperative and postoperative complications	Intraoperative and postoperative complications, such as shallow anterior chamber, malignant glaucoma, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and bleb-related complications.	Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
Secondary	The numbers of anti-glaucoma medications	Numbers of anti-glaucoma medications.	Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months