Back to resultsTrabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG (TVG)
Primary Purpose
Primary Angle Closure Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Trabeculectomy
SPI+GSL+GT
Sponsored by
About this trial
This is an interventional treatment trial for Primary Angle Closure Glaucoma focused on measuring angle closure, glaucoma
Eligibility Criteria
Inclusion Criteria:
- Age 45-80 years.
Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:
- PAS: ≥180° range, including nasal and inferior quadrants;
- IOP >21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer;
- 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);
- Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).
- No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);
- Axial length of ≥20 mm.
Exclusion Criteria:
- History of ocular surgery or trauma.
- 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.
- Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye).
- An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery.
- Patients with serious systemic diseases.
- 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.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Trabeculectomy
SPI+GSL+GT
Arm Description
Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.
Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT).
Outcomes
Primary Outcome Measures
Intraocular pressure at postoperative 12 months
Intraocular pressure after surgery using Goldmann or non-contact tonometer.
Secondary Outcome Measures
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.
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.
The numbers of anti-glaucoma medications
Numbers of anti-glaucoma medications.
Full Information
NCT ID
NCT05163951
First Posted
November 25, 2021
Last Updated
June 9, 2022
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
1. Study Identification
Unique Protocol Identification Number
NCT05163951
Brief Title
Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Angle Closure Glaucoma
Keywords
angle closure, glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter, parallel, open, non-inferior randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy.
Arm Title
SPI+GSL+GT
Arm Type
Experimental
Arm Description
Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT).
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
trabeculectomy
Intervention Type
Procedure
Intervention Name(s)
SPI+GSL+GT
Intervention Description
Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)
Primary Outcome Measure Information:
Title
Intraocular pressure at postoperative 12 months
Description
Intraocular pressure after surgery using Goldmann or non-contact tonometer.
Time Frame
Postoperative 12 month
Secondary Outcome Measure Information:
Title
Cumulative success rate of surgery
Description
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
Title
Intraoperative and postoperative complications
Description
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
Title
The numbers of anti-glaucoma medications
Description
Numbers of anti-glaucoma medications.
Time Frame
Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
Other Pre-specified Outcome Measures:
Title
Visual acuity
Description
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
Title
The degree of peripheral anterior synechia
Description
The peripheral anterior synechia is checked using gonioscopy. Range from 0-360° will be documented.
Time Frame
Postoperative 0, 3, 12, 24, 36 months
Title
Corneal endothelial cell counting
Description
Corneal endothelial cell counting will be documented using specular microscope.
Time Frame
Postoperative 0,12, 24, 36 months
Title
Visual field
Description
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
Title
Optic nerve head morphology
Description
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
Title
Retinal thickness
Description
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
Title
The quality of life
Description
Quality of life will be measured with EQ-5D-5L questionnaire.
Time Frame
Postoperative 0,12, 24, 36 months
Title
Filtering bleb classification
Description
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
Title
Surgical time
Description
Surgical time will be documented.
Time Frame
Postoperative 1 day
Title
Surgical cost
Description
Surgical cost will be documented.
Time Frame
Postoperative 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 45-80 years.
Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d:
PAS: ≥180° range, including nasal and inferior quadrants;
IOP >21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer;
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);
Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).
No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart);
Axial length of ≥20 mm.
Exclusion Criteria:
History of ocular surgery or trauma.
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.
Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye).
An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery.
Patients with serious systemic diseases.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiulan Zhang, MD. PhD
Phone
+86 13570166308
Email
zhangxl2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xinbo Gao, MD. PhD
Phone
+86 18319579657
Email
gaoxb@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiulan Zhang, MD. PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiulan Zhang, MD, PhD
Phone
+86 13059106657
Email
zhangxl2@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinbo Gao, MD, PhD
Phone
+86 18319579657
Email
gaoxb@mail.sysu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31294768
Citation
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Results Reference
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Citation
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Results Reference
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33671386
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):814. doi: 10.3390/jcm10040814.
Results Reference
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29613978
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.0000000000000956.
Results Reference
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PubMed Identifier
33031110
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.0000000000000321.
Results Reference
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PubMed Identifier
22986111
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 15.
Results Reference
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PubMed Identifier
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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: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
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Citation
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Results Reference
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Learn more about this trial
Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
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