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

Primary Purpose

Glaucoma, Angle-Closure

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy

phacoemulsification with intraocular lens implantation combined with trabeculectomy

About this trial

This is an interventional treatment trial for Glaucoma, Angle-Closure focused on measuring Glaucoma, Angle-Closure

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhongshan Ophthalmic Center
Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PEI+GSL+GT

PEI+Trab

Arm Description

Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Outcomes

Primary Outcome Measures

Mean change of intraocular pressure

Change from baseline IOP after surgery using Goldmann or non-contact tonometer.

Secondary Outcome Measures

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.

Intraoperative and postoperative complications

For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.

Anti-glaucomatous medications

Numbers and types of anti-glaucomatous medications

Full Information

NCT ID

NCT04878458

First Posted

May 6, 2021

Last Updated

August 27, 2023

Sponsor

Sun Yat-sen University

Collaborators

The Second Affiliated Hospital of Harbin Medical University, West China Hospital, First Hospital of Shijiazhuang City, Union hospital of Fujian Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Handan City Eye Hospital, Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04878458

Brief Title

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

Acronym

PVP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 31, 2021 (Actual)

Primary Completion Date

May 30, 2023 (Actual)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Angle-Closure

Keywords

Glaucoma, Angle-Closure

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

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PEI+GSL+GT

Arm Type

Experimental

Arm Description

Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

Arm Title

PEI+Trab

Arm Type

Experimental

Arm Description

Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Intervention Type

Procedure

Intervention Name(s)

phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy

Intervention Description

The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

Intervention Type

Procedure

Intervention Name(s)

phacoemulsification with intraocular lens implantation combined with trabeculectomy

Intervention Description

The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Primary Outcome Measure Information:

Title

Mean change of intraocular pressure

Description

Change from baseline IOP after surgery using Goldmann or non-contact tonometer.

Time Frame

Postoperative 12, 24, 36 months.

Secondary Outcome Measure Information:

Title

Cumulative success rate of surgery

Description

Time Frame

12, 24, 36 months

Title

Intraoperative and postoperative complications

Description

For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.

Time Frame

0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months

Title

Anti-glaucomatous medications

Description

Numbers and types of anti-glaucomatous medications

Time Frame

0, 1, 7 day. 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

0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months

Title

Degree of peripheral anterior synechia

Description

The peripheral anterior synechia is checked using gonioscopy.

Time Frame

3, 12, 24, 36 months

Title

Corneal endothelial cell counting

Description

Corneal endothelial cell counting will be documented using specular microscope.

Time Frame

0, 12, 24, 36 months

Title

Visual field

Description

Visual field examination is performed using Humphrey analyzer.

Time Frame

0, 12, 24, 36 months

Title

Optic nerve head morphology and retinal parameters

Description

Optic nerve head morphology and retinal parameters based on optical coherence tomography (Cirrus 5000, Zeiss, CA, USA or Spectralis, Heidelberg, Germany)

Time Frame

0, 12, 24, 36 months

Title

Measurement of quality of life

Description

Quality of life is measured with EQ-5D-5L questionnaire.

Time Frame

0, 12, 24, 36 months

Title

Filtering bleb classification

Description

Filtering bleb classification based on Indiana Bleb Appearance Grading Scale

Time Frame

12, 24, 36 months

Title

Time-consuming of operation and the surgery cost

Description

Time-consuming of operation and the surgery cost are based on the electronic healthy system.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Aged 40-80 years; Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4) At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes; IOP >21 mmHg with or without anti-glaucoma medication; 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); 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; 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; 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.

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

City

Guangzhou

State/Province

Guangdong

Country

China

Facility Name

Zhongshan Ophthalmic Center

City

Guangdong

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31294768

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.

Results Reference

result

PubMed Identifier

31976190

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.

Results Reference

result

PubMed Identifier

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

result

PubMed Identifier

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

result

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

result

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

result

PubMed Identifier

34880029

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.

Results Reference

derived

Learn more about this trial

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

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