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

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ClinicalTrials.gov Identifier: NCT05163951
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : June 14, 2022
Sponsor:
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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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)




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.



Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163951


Contacts
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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
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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
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Principal Investigator: Xiulan Zhang, MD. PhD Zhongshan Ophthalmic Center, Sun Yat-sen University
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases