Clinical trial NCT05163951: Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG
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
Overall status: RECRUITING
Phase: NA
Conditions: Primary Angle Closure Glaucoma
Keywords: angle closure
glaucoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
name: First Hospital of Shijiazhuang City
name: West China Hospital
name: Chongqing Medical University
name: Handan City Eye Hospital
name: People's Hospital of Chongqing
First posted: 2021-12-20
Enrollment: 88
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, parallel, open, non-inferior randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Intraocular pressure at postoperative 12 months
timeFrame: Postoperative 12 month
Secondary outcomes:
measure: Cumulative success rate of surgery
timeFrame: Postoperative 12, 24, 36 months
measure: Intraoperative and postoperative complications
timeFrame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
measure: The numbers of anti-glaucoma medications
timeFrame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
Other outcomes:
measure: Visual acuity
timeFrame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months
measure: The degree of peripheral anterior synechia
timeFrame: Postoperative 0, 3, 12, 24, 36 months
measure: Corneal endothelial cell counting
timeFrame: Postoperative 0,12, 24, 36 months
measure: Visual field
timeFrame: Postoperative 0,6,12, 24, 36 months
measure: Optic nerve head morphology
timeFrame: Postoperative 0,12, 24, 36 months
measure: Retinal thickness
timeFrame: Postoperative 0,12, 24, 36 months
measure: The quality of life
timeFrame: Postoperative 0,12, 24, 36 months
measure: Filtering bleb classification
timeFrame: Postoperative 3, 12, 24, 36 months
measure: Surgical time
timeFrame: Postoperative 1 day
measure: Surgical cost
timeFrame: Postoperative 1 day
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiulan Zhang, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
citation: 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.