Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT04878458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2021-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}, {'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}, {'id': 'D018463', 'term': 'Filtering Surgery'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, parallel, open, non-inferior randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months', 'description': 'Uncorrected and best corrected visual acuity will be documented using ETDRS chart.'}, {'measure': 'Degree of peripheral anterior synechia', 'timeFrame': '3, 12, 24, 36 months', 'description': 'The peripheral anterior synechia is checked using gonioscopy.'}, {'measure': 'Corneal endothelial cell counting', 'timeFrame': '0, 12, 24, 36 months', 'description': 'Corneal endothelial cell counting will be documented using specular microscope.'}, {'measure': 'Visual field', 'timeFrame': '0, 12, 24, 36 months', 'description': 'Visual field examination is performed using Humphrey analyzer.'}, {'measure': 'Optic nerve head morphology and retinal parameters', 'timeFrame': '0, 12, 24, 36 months', 'description': 'Optic nerve head morphology and retinal parameters based on optical coherence tomography (Cirrus 5000, Zeiss, CA, USA or Spectralis, Heidelberg, Germany)'}, {'measure': 'Measurement of quality of life', 'timeFrame': '0, 12, 24, 36 months', 'description': 'Quality of life is measured with EQ-5D-5L questionnaire.'}, {'measure': 'Filtering bleb classification', 'timeFrame': '12, 24, 36 months', 'description': 'Filtering bleb classification based on Indiana Bleb Appearance Grading Scale'}, {'measure': 'Time-consuming of operation and the surgery cost', 'timeFrame': '1 day', 'description': 'Time-consuming of operation and the surgery cost are based on the electronic healthy system.'}], 'primaryOutcomes': [{'measure': 'Mean change of intraocular pressure', 'timeFrame': 'Postoperative 12, 24, 36 months.', 'description': 'Change from baseline IOP after surgery using Goldmann or non-contact tonometer.'}], 'secondaryOutcomes': [{'measure': 'Cumulative success rate of surgery', 'timeFrame': '12, 24, 36 months', 'description': '(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.\n\n(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.'}, {'measure': 'Intraoperative and postoperative complications', 'timeFrame': '0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months', 'description': 'For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.'}, {'measure': 'Anti-glaucomatous medications', 'timeFrame': '0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months', 'description': 'Numbers and types of anti-glaucomatous medications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma, Angle-Closure'], 'conditions': ['Glaucoma, Angle-Closure']}, 'referencesModule': {'references': [{'pmid': '31294768', 'type': 'BACKGROUND', '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.'}, {'pmid': '31976190', 'type': 'BACKGROUND', '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.'}, {'pmid': '33671386', 'type': 'BACKGROUND', '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.'}, {'pmid': '29613978', 'type': 'BACKGROUND', '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.'}, {'pmid': '33031110', 'type': 'BACKGROUND', '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.'}, {'pmid': '22986111', 'type': 'BACKGROUND', '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.'}, {'pmid': '38795868', 'type': 'RESULT', '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.'}, {'pmid': '38383075', 'type': 'RESULT', '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.'}, {'pmid': '40244620', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34880029', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWith 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.\n\nTherefore, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion criteria\n\n 1. Aged 40-80 years;\n 2. Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)\n\n 1. At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes;\n 2. IOP \\>21 mmHg with or without anti-glaucoma medication;\n 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);\n 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;\n 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;\n 4. Voluntarily participate in study and provide signed informed consent.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04878458', 'acronym': 'PVP', 'briefTitle': 'Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021KYPJ090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEI+GSL+GT', 'description': 'Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.', 'interventionNames': ['Procedure: phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy']}, {'type': 'EXPERIMENTAL', 'label': 'PEI+Trab', 'description': 'Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.', 'interventionNames': ['Procedure: phacoemulsification with intraocular lens implantation combined with trabeculectomy']}], 'interventions': [{'name': 'phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy', 'type': 'PROCEDURE', 'description': 'The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.', 'armGroupLabels': ['PEI+GSL+GT']}, {'name': 'phacoemulsification with intraocular lens implantation combined with trabeculectomy', 'type': 'PROCEDURE', 'description': 'The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.', 'armGroupLabels': ['PEI+Trab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 42.76832, 'lon': 129.33635}}], 'overallOfficials': [{'name': 'Xiulan Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'First Hospital of Shijiazhuang City', 'class': 'OTHER'}, {'name': 'Union hospital of Fujian Medical University', 'class': 'OTHER'}, {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, {'name': 'Handan City Eye Hospital', 'class': 'UNKNOWN'}, {'name': 'Chongqing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Clinical Research Center', 'investigatorFullName': 'Xiulan Zhang', 'investigatorAffiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}}}}