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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEI combined with gonioscopy-assisted trabeculotomy | Experimental | 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. |
|
| PEI combined with conventional IOP-lowering medications | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEI combined with gonioscopy-assisted trabeculotomy | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in intraocular pressure from baseline to 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete success rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tear-fluid biomarker levels | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyang Zhang, PhD | Contact | +86-20-62787325 | hy3005716@163.com | |
| Yuqiao Zhang, PhD | Contact | yqzhang@link.cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital of Ningxia Hui Autonomous Region | Not yet recruiting | Ningxia | Ningxia | China | ||
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|
| PEI combined with conventional topical IOP-lowering medications | Combination Product | 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. |
|
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 | 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 | Best-corrected visual acuity will be recorded and converted to LogMAR for analysis. | Baseline through Month 24 |
| Visual field indices | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized. | 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 |
| Nanfang Hospital, Southern Medical University |
| Recruiting |
| Guangzhou |
| China |
|
| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | China |
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | China |
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| Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine | Not yet recruiting | Zhuhai | China |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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