PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorNanfang Hospital, Southern Medical University
About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PEI combined with gonioscopy-assisted trabeculotomy
Combination productPhacoemulsification 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.
PEI combined with conventional topical IOP-lowering medications
Combination productPhacoemulsification 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.
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: PEI combined with gonioscopy-assisted trabeculotomyExperimental treatment 1 intervention
Group B: PEI combined with conventional IOP-lowering medicationsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Month 24Secondary outcomes
1
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.
Time frame
Month 242
Qualified success rate
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.
Time frame
Month 243
Number of IOP-lowering medications
Number and class of topical IOP-lowering medications used at each follow-up visit.
Time frame
Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 244
Best-corrected visual acuity
Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.
Time frame
Baseline through Month 24Other outcomes
1
Tear-fluid biomarker levels
Tear-fluid biomarkers include matrix metalloproteinase (MMP), interleukin-13 (IL-13), and tumor necrosis factor-alpha (TNF-alpha).
Time frame
Baseline and Month 242
Surgery-drug benefit index
Composite exploratory index integrating IOP control, medication reduction, structural preservation, ocular surface status, quality of life, safety, and economic outcomes.
Time frame
Baseline through Month 24Sponsors and contacts
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Source ClinicalTrials.gov