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Status unknownNCT05163951TVGUpdated Jun 14, 2022

Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

An interventional study of Trabeculectomy and SPI+GSL+GT in Primary Angle Closure Glaucoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-06-14.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Angle Closure Glaucoma

Keywords

  • angle closure
  • glaucoma
03

In context

Glaucoma, Angle-Closure

97 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.

This study's planned enrollment of 88 is above the median of 59 across 61 interventional studies indexed under Glaucoma, Angle-Closure.

Browse Glaucoma, Angle-Closure studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

Browse Sun Yat-sen University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Active comparator
    Trabeculectomy

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

    Procedure: 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

Interventions

  • ProcedureTrabeculectomy

    trabeculectomy

  • ProcedureSPI+GSL+GT

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

06

What researchers measure

Primary outcomes

  1. Intraocular pressure at postoperative 12 months

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

    Time frame: Postoperative 12 month

Secondary outcomes

  1. 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.

    Time frame: Postoperative 12, 24, 36 months

  2. 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.

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

  3. The numbers of anti-glaucoma medications

    Numbers of anti-glaucoma medications.

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

Other outcomes

  1. Visual acuity

    Uncorrected and best corrected visual acuity will be documented using ETDRS chart.

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

  2. The degree of peripheral anterior synechia

    The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented.

    Time frame: Postoperative 0, 3, 12, 24, 36 months

  3. Corneal endothelial cell counting

    Corneal endothelial cell counting will be documented using specular microscope.

    Time frame: Postoperative 0,12, 24, 36 months

  4. Visual field

    Visual field will be performed using Humphrey analyzer, in which parameters of mean deviation (MD), pattern standard deviation (PSD) will be documented.

    Time frame: Postoperative 0,6,12, 24, 36 months

  5. 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).

    Time frame: Postoperative 0,12, 24, 36 months

  6. Retinal thickness

    Retinal thickness will be derived from optical coherence tomography (Cirrus 5000, Carl Zeiss Meditec, USA or Heidelberg OCT, SPECTRALIS OCT, Heidelberg, Germany).

    Time frame: Postoperative 0,12, 24, 36 months

  7. The quality of life

    Quality of life will be measured with EQ-5D-5L questionnaire.

    Time frame: Postoperative 0,12, 24, 36 months

  8. Filtering bleb classification

    Filtering bleb classification using the Indiana Bleb Appearance Grading Scale, including height, width, extent, vascularity, and Seidel test.

    Time frame: Postoperative 3, 12, 24, 36 months

  9. Surgical time

    Surgical time will be documented.

    Time frame: Postoperative 1 day

  10. Surgical cost

    Surgical cost will be documented.

    Time frame: Postoperative 1 day

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 31294768 ↗
  • 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. PubMed 31976190 ↗
  • 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. PubMed 33671386 ↗
  • 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. PubMed 29613978 ↗
  • 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. PubMed 33031110 ↗
  • 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. PubMed 22986111 ↗
  • 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. PubMed 31727428 ↗
  • 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. PubMed 40244579 ↗
  • 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. PubMed 35788072 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Jun 2024, 29 months after the start.

Of 29 interventional studies with no phase under Glaucoma, Angle-Closure, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 29 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2021
First posted
Dec 20, 2021
StartActual
Jan 5, 2022
Primary completionEst.
Jun 30, 2024
CompletionEst.
Jun 30, 2026
Last update
Jun 14, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05163951
Lead sponsor
Sun Yat-sen University
Collaborators
The Second Affiliated Hospital of Harbin Medical University, First Hospital of Shijiazhuang City, West China Hospital, Chongqing Medical University, Handan City Eye Hospital, People's Hospital of Chongqing
Responsible party
Xiulan Zhang (Director of Clinical Research Center, Sun Yat-sen University) — Principal investigator
First posted
Dec 20, 2021
Start date
Jan 5, 2022
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jun 14, 2022

Study contacts

Xiulan Zhang, MD. PhD
Contact
zhangxl2@mail.sysu.edu.cn
+86 13570166308
Xinbo Gao, MD. PhD
Contact
gaoxb@mail.sysu.edu.cn
+86 18319579657
Xiulan Zhang, MD. PhD
principal investigator · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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