NCT07700498Toboroz
PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 14.
Rövid összefoglaló (regiszter, angolul)
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
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 106 (tervezett)
- Első benyújtás
- 2026. júl. 7.
- Kezdés
- 2026. júl. 15.
- Elsődleges befejezés
- 2029. dec. 31.
- Fő szponzor
- Nanfang Hospital, Southern Medical University
- Betegségek
- Zöldhályog (glaukóma)
- NCT-szám
- NCT07700498
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 106
- 2026. júl. 15. és az elsődleges befejezés (2029. dec. 31.) között
- 5 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.
- Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.
- Known contraindication to required study medications.
Más betegség
- 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.
Egyéb
- Angle-closure glaucoma or narrow angle inconsistent with POAG.
- POAG without visually significant cataract.
- 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.
- 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.
- Pregnancy, lactation, or planned pregnancy during the study period.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 40 év – 85 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (5)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Kína | Toboroz |
| The Affiliated Hospital of Southwest Medical University | Luzhou | Kína | Toborzás még nem indult |
| People's Hospital of Ningxia Hui Autonomous Region | Ningxia | Kína | Toborzás még nem indult |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Kína | Toborzás még nem indult |
| Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine | Zhuhai | Kína | Toborzás még nem indult |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.