Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma

Glaucoma, Angle-Closure Clinical Trial

— PVP  

Official title:

Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04878458
• Other study ID #: 2021KYPJ090
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: June 30, 2025
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Angle-Closure

Intervention

Procedure:
• phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy
The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
• phacoemulsification with intraocular lens implantation combined with trabeculectomy
The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangdong
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (8)

Lead Sponsor	Collaborator
Sun Yat-sen University	Chongqing Medical University, First Hospital of Shijiazhuang City, Handan City Eye Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The Second Affiliated Hospital of Harbin Medical University, Union hospital of Fujian Medical University, West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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.0000000000 — View 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.00000000 — View 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 Ophth — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual acuity	Uncorrected and best corrected visual acuity will be documented using ETDRS chart.	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Other	Degree of peripheral anterior synechia	The peripheral anterior synechia is checked using gonioscopy.	3, 12, 24, 36 months
Other	Corneal endothelial cell counting	Corneal endothelial cell counting will be documented using specular microscope.	0, 12, 24, 36 months
Other	Visual field	Visual field examination is performed using Humphrey analyzer.	0, 12, 24, 36 months
Other	Optic nerve head morphology and retinal parameters	Optic nerve head morphology and retinal parameters based on optical coherence tomography (Cirrus 5000, Zeiss, CA, USA or Spectralis, Heidelberg, Germany)	0, 12, 24, 36 months
Other	Measurement of quality of life	Quality of life is measured with EQ-5D-5L questionnaire.	0, 12, 24, 36 months
Other	Filtering bleb classification	Filtering bleb classification based on Indiana Bleb Appearance Grading Scale	12, 24, 36 months
Other	Time-consuming of operation and the surgery cost	Time-consuming of operation and the surgery cost are based on the electronic healthy system.	1 day
Primary	Mean change of intraocular pressure	Change from baseline IOP after surgery using Goldmann or non-contact tonometer.	Postoperative 12, 24, 36 months.
Secondary	Cumulative success rate of surgery	(i) Complete success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with no need for IOP-lowering medication.; (ii) Qualified success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with or without IOP-lowering medication.	12, 24, 36 months
Secondary	Intraoperative and postoperative complications	For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months
Secondary	Anti-glaucomatous medications	Numbers and types of anti-glaucomatous medications	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months