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

7. juli 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

106

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
      • Guangzhou, Kina
        • Rekruttering
        • Nanfang Hospital, Southern Medical University
        • Kontakt:
      • Luzhou, Kina
        • Ikke rekrutterer endnu
        • The Affiliated Hospital of Southwest Medical University
      • Zhengzhou, Kina
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
          • Xin Yang
      • Zhuhai, Kina
        • Ikke rekrutterer endnu
        • Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
    • Ningxia
      • Ningxia, Ningxia, Kina
        • Ikke rekrutterer endnu
        • People's Hospital of Ningxia Hui Autonomous Region

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kombinationsprodukt: 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.
Aktiv komparator: 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.
Kombinationsprodukt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean change in intraocular pressure from baseline to Month 24
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Complete success rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline through Month 24
Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.
Baseline through Month 24
Visual field indices
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tear-fluid biomarker levels
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanfang Hospital, Southern Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juli 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

7. juli 2026

Først indsendt, der opfyldte QC-kriterier

7. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NFEC-2026-303

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