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PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract

7 luglio 2026 aggiornato da: 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

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

106

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Hongyang Zhang, PhD
  • Numero di telefono: +86-20-62787325
  • Email: hy3005716@163.com

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Guangzhou, Cina
        • Reclutamento
        • Nanfang Hospital, Southern Medical University
        • Contatto:
      • Luzhou, Cina
        • Non ancora reclutamento
        • The Affiliated Hospital of Southwest Medical University
      • Zhengzhou, Cina
        • Non ancora reclutamento
        • The First Affiliated Hospital of Zhengzhou University
        • Contatto:
          • Xin Yang
      • Zhuhai, Cina
        • Non ancora reclutamento
        • Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
    • Ningxia
      • Ningxia, Ningxia, Cina
        • Non ancora reclutamento
        • People's Hospital of Ningxia Hui Autonomous Region

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Prodotto combinato: PEI combined with gonioscopy-assisted trabeculotomy
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.
Comparatore attivo: 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.
Prodotto combinato: PEI combined with conventional topical IOP-lowering medications
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean change in intraocular pressure from baseline to Month 24
Lasso di tempo: Baseline and Month 24
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.
Baseline and Month 24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Complete success rate
Lasso di tempo: 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.
Month 24
Qualified success rate
Lasso di tempo: Month 24
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.
Month 24
Number of IOP-lowering medications
Lasso di tempo: Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Number and class of topical IOP-lowering medications used at each follow-up visit.
Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Best-corrected visual acuity
Lasso di tempo: Baseline through Month 24
Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.
Baseline through Month 24
Visual field indices
Lasso di tempo: Baseline, Month 6, Month 12, Month 18, and Month 24
Humphrey visual field 30-2 SITA Standard indices, including mean deviation and pattern standard deviation, will be recorded with reliability criteria.
Baseline, Month 6, Month 12, Month 18, and Month 24
Retinal nerve fiber layer thickness
Lasso di tempo: Baseline, Month 6, Month 12, Month 18, and Month 24
Peripapillary retinal nerve fiber layer thickness will be measured by OCT.
Baseline, Month 6, Month 12, Month 18, and Month 24
Ganglion cell-inner plexiform layer thickness
Lasso di tempo: Baseline, Month 6, Month 12, Month 18, and Month 24
Macular ganglion cell-inner plexiform layer thickness will be measured by OCT.
Baseline, Month 6, Month 12, Month 18, and Month 24
Anterior segment parameters by AS-OCT
Lasso di tempo: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
AS-OCT parameters may include anterior chamber depth, angle opening distance, trabecular-iris space area, and other protocol-specified anterior segment findings.
Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Ocular surface parameters
Lasso di tempo: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
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.
Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
NEI VFQ-25 score
Lasso di tempo: Baseline, Month 6, Month 12, Month 18, and Month 24
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 total score.
Baseline, Month 6, Month 12, Month 18, and Month 24
GAD-7 score
Lasso di tempo: Baseline, Month 6, Month 12, Month 18, and Month 24
Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale total score.
Baseline, Month 6, Month 12, Month 18, and Month 24
Incidence of adverse events
Lasso di tempo: Day 1 through Month 24
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.
Day 1 through Month 24
Health economic indicators
Lasso di tempo: Baseline through Month 24
Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized.
Baseline through Month 24

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Tear-fluid biomarker levels
Lasso di tempo: Baseline and Month 24
Tear-fluid biomarkers include matrix metalloproteinase (MMP), interleukin-13 (IL-13), and tumor necrosis factor-alpha (TNF-alpha).
Baseline and Month 24
Surgery-drug benefit index
Lasso di tempo: Baseline through Month 24
Composite exploratory index integrating IOP control, medication reduction, structural preservation, ocular surface status, quality of life, safety, and economic outcomes.
Baseline through Month 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nanfang Hospital, Southern Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

31 dicembre 2029

Completamento dello studio (Stimato)

31 dicembre 2030

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

14 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NFEC-2026-303

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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