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Glaucoma, Angle-ClosurePVPNCT04878458

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

A study testing phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy and phacoemulsification with intraocular lens implantation combined with trabeculectomy in people with Glaucoma, Angle-Closure, run by Sun Yat-sen University at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Glaucoma, Angle-Closure
What is being tested?
phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy and phacoemulsification with intraocular lens implantation combined with trabeculectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
2 sitesChina
Study dates
31 May 2021to 30 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 9Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhongshan Ophthalmic Center

    Guangdong

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong

Other trials in China

About this study

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

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.

Read the 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.

Being tested
phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy, phacoemulsification with intraocular lens implantation combined with trabeculectomy
Keywords
Glaucoma, Angle-Closure
Medical subject headings
Glaucoma, Angle-Closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomyProcedure or surgery

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

  • phacoemulsification with intraocular lens implantation combined with trabeculectomyProcedure or surgery

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

Study groups in NCT04878458
Study groupRoleWhat they receive
PEI+GSL+GTExperimentalSixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
Receives: Procedure: phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy
PEI+TrabExperimentalSixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.
Receives: Procedure: phacoemulsification with intraocular lens implantation combined with trabeculectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change of intraocular pressure

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

    Measured: Postoperative 12, 24, 36 months.

Secondary outcomes (3)

  1. 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.

    Measured: 12, 24, 36 months

  2. Intraoperative and postoperative complications

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

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

  3. Anti-glaucomatous medications

    Numbers and types of anti-glaucomatous medications

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start31 May 2021
  3. Primary completion30 May 2023
  4. Study completion30 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter, parallel, open, non-inferior randomized controlled trial
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878458
Sponsor's protocol ID
2021KYPJ090
Acronym
PVP
Status last verified
Dec 2024
First submitted
6 May 2021
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31294768

  • 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.

    PubMed 31976190

  • 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.

    PubMed 33671386

  • 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.

    PubMed 29613978

  • 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.

    PubMed 33031110

  • 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.

    PubMed 22986111

  • 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.

    PubMed 38795868

  • 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.

    PubMed 38383075

  • Song Y, Fan S, Tang L, Lin F, Li F, Lv A, Li X, Wen T, Lu L, Xiao M, Xie L, Zhu X, Tang G, Zhang H, Yan X, Yuan H, Song W, Yang Y, Xu J, Zhou F, Wang Z, Jin L, Liang X, Zhou M, Zhao X, Chen W, Park KH, Barton K, Aung T, Tham CC, Lam DSC, Weinreb RN, Wang N, Zhang X; PVP Study Group. Two-Year Outcomes of Phacogoniotomy vs Phacotrabeculectomy for Advanced Primary Angle-Closure Glaucoma With Cataract: A Noninferiority Randomized Clinical Trial. JAMA Ophthalmol. 2025 Jun 1;143(6):462-469. doi: 10.1001/jamaophthalmol.2025.0685.

    PubMed 40244620

  • 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.

    PubMed 34880029

Questions about this trial

What is this clinical trial studying?

A study testing phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy and phacoemulsification with intraocular lens implantation combined with trabeculectomy in people with Glaucoma, Angle-Closure, run by Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change of intraocular pressure (time frame: Postoperative 12, 24, 36 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878458, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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