Clinical trial NCT04878458: Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
Official title: Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Glaucoma, Angle-Closure
Keywords: Glaucoma, Angle-Closure
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
name: West China Hospital
name: First Hospital of Shijiazhuang City
name: Union hospital of Fujian Medical University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Handan City Eye Hospital
name: Chongqing Medical University
First posted: 2021-05-07
Enrollment: 124
Sex: ALL
Minimum age (years): 40
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 was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.

Detailed description: Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method is anti-glaucoma surgery-trabeculectomy (Trab) combined with lens extraction. Phacotrabeculectomy has become the first-line choice of anti-glaucoma suregery in the treatment of advanced PACG. However, it was not an ideal method due to the bleb-related complications and troublesome postoperative nursing, as well as the difficulty for surgeons, caused by trabeculectomy. However, recent studies revealed that the phacoemulsification with intraocular lens implantation (PEI) combined with goniosynechialysis (GSL) has achieved efficacy in the treatment of PACG.

With the advent of minimally invasive glaucoma surgeries (MIGS), there is an increasing number studies indicating the MIGS performed great efficacy in the treatment of primary open angle glaucoma. While,there were a few small-sampled retrospective studies which showed therapeutic effects in PACG. The GSL plus goniotomy (GT) could achieve great efficacy in lowering the intraocular pressure of PACG patients. However, there is still a lack of high quality and high-level randomized controlled trials.

Therefore, this study intends to conduct a multicenter, parallel, open, non-inferior randomized controlled trial to compare the effectiveness and safety of PEI+ Trab and PEI+GSL+GT in the treatment of advanced PACG, so as to provide a better surgical treatment for PACG.

Eligibility criteria: * Inclusion criteria

  1. Aged 40-80 years;
  2. Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)

     1. At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes;
     2. IOP \>21 mmHg with or without anti-glaucoma medication;
     3. Obvious glaucomatous optic neuropathy (cup-to-disc \[C/D\] ratio≥0.7, or C/D asymmetry \> 0.2, or the rim width at the superior and inferior temporal \< 0.1 vertical diameters of optic disc);
     4. With glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer using SITA-Standard 24-2 or 30-2 algorithm; mean deviation ≤ -12dB;
  3. Clinically obvious cataract and uncorrected visual acuity (UCVA) \<0.63 (Early Treatment Diabetic Retinopathy Study, \[ETDRS\] chart), or need lens extraction assessed by a clinician;
  4. Voluntarily participate in study and provide signed informed consent.
* Exclusion criteria a. History of ocular surgery (other than laser iridotomy or laser iriplasty) or trauma; b. With other types of glaucoma; (i.e. open angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle regression glaucoma, neovascular glaucoma, nanophthalmos, pseudoexfoliation syndrome) c. The International Standardized Ratio \> 3.0 for patients receiving warfarin or anticoagulant therapy before surgery; d. With retinal disease that affects the collection of ocular parameters; f. Monophthalmia (best-corrected visual acuity \[BCVA\] \<0.01 in the non-study eye); g. With other serious systemic diseases; h. Pregnant or lactating women \* If both eyes are eligible for the study, the eye with the worse UCVA will be recruited.

Primary outcomes:
measure: Mean change of intraocular pressure
timeFrame: Postoperative 12, 24, 36 months.
Secondary outcomes:
measure: Cumulative success rate of surgery
timeFrame: 12, 24, 36 months
measure: Intraoperative and postoperative complications
timeFrame: 0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
measure: Anti-glaucomatous medications
timeFrame: 0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Other outcomes:
measure: Visual acuity
timeFrame: 0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
measure: Degree of peripheral anterior synechia
timeFrame: 3, 12, 24, 36 months
measure: Corneal endothelial cell counting
timeFrame: 0, 12, 24, 36 months
measure: Visual field
timeFrame: 0, 12, 24, 36 months
measure: Optic nerve head morphology and retinal parameters
timeFrame: 0, 12, 24, 36 months
measure: Measurement of quality of life
timeFrame: 0, 12, 24, 36 months
measure: Filtering bleb classification
timeFrame: 12, 24, 36 months
measure: Time-consuming of operation and the surgery cost
timeFrame: 1 day
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
city: Guangdong
country: China
facility: Zhongshan Ophthalmic Center
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiulan Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 Ophthalmol. 2019 Oct 1;137(10):1107-1113. doi: 10.1001/jamaophthalmol.2019.2493.
citation: 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.
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.
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.
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: Song Y, Li F, Zhang X. Response: Comment on "Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial". Asia Pac J Ophthalmol (Phila). 2024 May-Jun;13(3):100076. doi: 10.1016/j.apjo.2024.100076. Epub 2024 May 23. No abstract available.
citation: Song Y, Lin F, Lv A, Zhang Y, Lu L, Xie L, Tang G, Yuan H, Yang Y, Xu J, Lu P, Xiao M, Zhu X, Yan X, Song W, Li X, Zhang H, Li F, Wang Z, Jin L, Gao X, Liang X, Zhou M, Zhao X, Zhang Y, Chen W, Wang N, Tham CC, Barton K, Park KH, Aung T, Weinreb RN, Tang L, Fan S, Lam DSC, Zhang X; PVP Study group. Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial. Asia Pac J Ophthalmol (Phila). 2024 Jan-Feb;13(1):100033. doi: 10.1016/j.apjo.2023.100033. Epub 2023 Dec 26.
citation: Song Y, Song W, Zhang Y, Zhang H, Xiao M, Zhao X, Lv A, Yan X, Lu P, Zhu X, Gao X, Hu K, Zhang Y, Liang X, Zhang X, Tang G, Lu L, Zhou M, Fan S, Xie L, Jin L, Tang L, Yuan H, Zhang X; PVP Study group. Efficacy and safety of phacotrabeculectomy versus phacogoniotomy in advanced primary angle-closure glaucoma: study protocol for a multicentre non-inferiority randomised controlled trial (PVP Study). BMJ Open. 2021 Dec 8;11(12):e056876. doi: 10.1136/bmjopen-2021-056876.