PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract
7. července 2026 aktualizováno: Nanfang Hospital, Southern Medical University
Efficacy and Safety of Phacoemulsification Combined With Gonioscopy-Assisted Trabeculotomy as Initial Treatment for Primary Open-Angle Glaucoma With Cataract: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to learn whether doing phacoemulsification combined with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the burden of glaucoma eye drops in adults with primary open-angle glaucoma and cataract. It will also learn whether this early surgical strategy improves ocular surface health and vision-related quality of life. The main questions it aims to answer are:
Does early combined surgery reduce the need for long-term glaucoma medications? Does early combined surgery improve ocular surface health compared with cataract surgery followed by guideline-based glaucoma eye drops? Does early combined surgery improve vision-related quality of life and anxiety compared with the medication-based treatment strategy? What medical problems or complications do participants have after treatment? Researchers will compare phacoemulsification combined with gonioscopy-assisted trabeculotomy to phacoemulsification followed by guideline-based topical eye pressure-lowering medications.
Participants will:
Undergo cataract surgery with or without gonioscopy-assisted trabeculotomy Attend follow-up visits for 24 months after treatment Have eye pressure, visual acuity, OCT, AS-OCT, visual field, ocular surface, and safety examinations at scheduled visits Complete quality-of-life and anxiety questionnaires at scheduled visits Provide tear samples at selected visits for biomarker testing where applicable
Přehled studie
Postavení
Nábor
Detailní popis
Primary open-angle glaucoma is a chronic progressive optic neuropathy in which sustained intraocular pressure control is important for delaying structural and functional progression.
Long-term topical IOP-lowering medication may be limited by ocular surface disease, poor adherence, treatment cost, and cumulative ocular tissue exposure.
Gonioscopy-assisted trabeculotomy is an ab interno minimally invasive glaucoma procedure that can be combined with phacoemulsification in patients with coexisting cataract.
This trial will compare PEI plus GT with PEI plus conventional medications as an initial treatment strategy in treatment-naive patients with POAG and cataract.
Randomization will be stratified by center and implemented through an IWRS or equivalent web-based randomization system.
Outcome assessors will be masked whenever feasible.
Follow-up visits are scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24.
Typ studie
Intervenční
Zápis (Odhadovaný)
106
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Hongyang Zhang, PhD
- Telefonní číslo: +86-20-62787325
- E-mail: hy3005716@163.com
Studijní záloha kontaktů
- Jméno: Yuqiao Zhang, PhD
- E-mail: yqzhang@link.cuhk.edu.hk
Studijní místa
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Guangzhou, Čína
- Nábor
- Nanfang Hospital, Southern Medical University
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Kontakt:
- Hongyang Zhang
- Telefonní číslo: +86-20-62787325
- E-mail: hy3005716@163.com
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Luzhou, Čína
- Zatím nenabíráme
- The Affiliated Hospital of Southwest Medical University
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Zhengzhou, Čína
- Zatím nenabíráme
- The First Affiliated Hospital of Zhengzhou University
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Kontakt:
- Xin Yang
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Zhuhai, Čína
- Zatím nenabíráme
- Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
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Ningxia
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Ningxia, Ningxia, Čína
- Zatím nenabíráme
- People's Hospital of Ningxia Hui Autonomous Region
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Provides written informed consent voluntarily.
- Age 40 to 85 years.
- Male or female.
- Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery.
- Lens opacity causing decreased visual quality and clinically significant cataract.
- Diagnosis of POAG combined with cataract by the treating ophthalmologist.
- Best-corrected visual acuity of 0.1 or better on the Snellen chart, corresponding to LogMAR 1.0 or less.
- Ability and willingness to complete scheduled follow-up visits and study examinations.
Exclusion Criteria:
- Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.
- Angle-closure glaucoma or narrow angle inconsistent with POAG.
- POAG without visually significant cataract.
- Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.
- Advanced visual field loss, defined as visual field mean deviation worse than -12 dB.
- Severe ocular comorbidity or inability to perform reliable visual acuity testing.
- Known contraindication to required study medications.
- Average RNFL thickness or GCIPL thickness less than 54 micrometers.
- Axial length greater than 26 mm.
- Monocular status or functional vision in only one eye.
- Inability to complete reliable visual field or OCT testing.
- Systemic disease that may affect ocular status or study assessment, including diabetes mellitus, uncontrolled hypertension, malignancy, renal disease, autoimmune disease, neurological disease, liver disease, cardiovascular disease, or systemic inflammatory disease.
- Visual impairment mainly attributable to disease other than POAG or cataract.
- Pregnancy, lactation, or planned pregnancy during the study period.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: PEI combined with gonioscopy-assisted trabeculotomy
Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation combined with approximately 120 degrees of ab interno gonioscopy-assisted trabeculotomy during the same surgical session.
Postoperative care will follow the protocol, and rescue IOP-lowering medications may be added if clinically indicated.
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Phacoemulsification combined with Ab interno trabeculotomy performed under gonioscopic visualization for approximately 120 degrees to incise/open the trabecular meshwork and expose Schlemm canal.
The cutting instrument will be non-device-dependent, such as a Tanito hook, Lanxin knife, Zeng knife, or bent 25-26G needle; KDB is not included as the cutting blade.
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Aktivní komparátor: PEI combined with conventional IOP-lowering medications
Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation.
Postoperatively, conventional topical IOP-lowering medications will be initiated or adjusted according to guideline-based care and clinical judgment when IOP remains above target.
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Phacoemulsification combined with guideline-based topical IOP-lowering therapy, generally including prostaglandin analogues unless contraindicated, with beta-blockers, carbonic anhydrase inhibitors, alpha-2 agonists, or other agents added or adjusted according to efficacy, tolerance, contraindications, and clinical judgment.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Mean change in intraocular pressure from baseline to Month 24
Časové okno: Baseline and Month 24
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Intraocular pressure will be measured in mmHg, preferably by Goldmann applanation tonometry.
Change will be calculated as Month 24 IOP minus baseline IOP and compared between groups.
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Baseline and Month 24
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Complete success rate
Časové okno: Month 24
|
Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, without additional IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.
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Month 24
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Qualified success rate
Časové okno: Month 24
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Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, with or without IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.
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Month 24
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Number of IOP-lowering medications
Časové okno: Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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Number and class of topical IOP-lowering medications used at each follow-up visit.
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Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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Best-corrected visual acuity
Časové okno: Baseline through Month 24
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Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.
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Baseline through Month 24
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Visual field indices
Časové okno: Baseline, Month 6, Month 12, Month 18, and Month 24
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Humphrey visual field 30-2 SITA Standard indices, including mean deviation and pattern standard deviation, will be recorded with reliability criteria.
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Baseline, Month 6, Month 12, Month 18, and Month 24
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Retinal nerve fiber layer thickness
Časové okno: Baseline, Month 6, Month 12, Month 18, and Month 24
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Peripapillary retinal nerve fiber layer thickness will be measured by OCT.
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Baseline, Month 6, Month 12, Month 18, and Month 24
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Ganglion cell-inner plexiform layer thickness
Časové okno: Baseline, Month 6, Month 12, Month 18, and Month 24
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Macular ganglion cell-inner plexiform layer thickness will be measured by OCT.
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Baseline, Month 6, Month 12, Month 18, and Month 24
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Anterior segment parameters by AS-OCT
Časové okno: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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AS-OCT parameters may include anterior chamber depth, angle opening distance, trabecular-iris space area, and other protocol-specified anterior segment findings.
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Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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Ocular surface parameters
Časové okno: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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Ocular surface assessment includes lipid layer thickness, tear meniscus height, non-invasive tear break-up time, meibomian gland structure, conjunctival hyperemia, and corneal fluorescein staining.
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Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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NEI VFQ-25 score
Časové okno: Baseline, Month 6, Month 12, Month 18, and Month 24
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Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 total score.
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Baseline, Month 6, Month 12, Month 18, and Month 24
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GAD-7 score
Časové okno: Baseline, Month 6, Month 12, Month 18, and Month 24
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Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale total score.
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Baseline, Month 6, Month 12, Month 18, and Month 24
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Incidence of adverse events
Časové okno: Day 1 through Month 24
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Ocular and systemic adverse events and serious adverse events will be recorded, including IOP spike, hypotony, hyphema, corneal edema, anterior chamber inflammation, posterior capsule opacification, infection, and need for additional glaucoma surgery.
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Day 1 through Month 24
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Health economic indicators
Časové okno: Baseline through Month 24
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Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized.
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Baseline through Month 24
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tear-fluid biomarker levels
Časové okno: Baseline and Month 24
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Tear-fluid biomarkers include matrix metalloproteinase (MMP), interleukin-13 (IL-13), and tumor necrosis factor-alpha (TNF-alpha).
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Baseline and Month 24
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Surgery-drug benefit index
Časové okno: Baseline through Month 24
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Composite exploratory index integrating IOP control, medication reduction, structural preservation, ocular surface status, quality of life, safety, and economic outcomes.
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Baseline through Month 24
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
15. července 2026
Primární dokončení (Odhadovaný)
31. prosince 2029
Dokončení studie (Odhadovaný)
31. prosince 2030
Termíny zápisu do studia
První předloženo
7. července 2026
První předloženo, které splnilo kritéria kontroly kvality
7. července 2026
První zveřejněno (Aktuální)
14. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
7. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NFEC-2026-303
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