Primary Open Angle Glaucoma and Cataracts
Conditions
Brief summary
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
Detailed description
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.
Interventions
COMBINATION_PRODUCTPEI 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.
COMBINATION_PRODUCTPEI 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in intraocular pressure from baseline to Month 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete success rate | 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. |
| Qualified success rate | 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. |
| Number of IOP-lowering medications | 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. |
| Best-corrected visual acuity | Baseline through Month 24 | Best-corrected visual acuity will be recorded and converted to LogMAR for analysis. |
| Visual field indices | 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. |
| Retinal nerve fiber layer thickness | Baseline, Month 6, Month 12, Month 18, and Month 24 | Peripapillary retinal nerve fiber layer thickness will be measured by OCT. |
| Ganglion cell-inner plexiform layer thickness | Baseline, Month 6, Month 12, Month 18, and Month 24 | Macular ganglion cell-inner plexiform layer thickness will be measured by OCT. |
| Anterior segment parameters by AS-OCT | 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. |
| Ocular surface parameters | 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. |
| NEI VFQ-25 score | 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. |
| GAD-7 score | Baseline, Month 6, Month 12, Month 18, and Month 24 | Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale total score. |
| Incidence of adverse events | 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. |
| Health economic indicators | Baseline through Month 24 | Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized. |
Countries
China
Contacts
CONTACTHongyang Zhang, PhD
CONTACTYuqiao Zhang, PhD
Outcome results
None listed