Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma (NCT04878458) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
China124 participantsStarted 2021-05-31
Plain-language summary
A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.
Who can participate
Age range
40 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged 40-80 years;
. Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)
. At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes;
. IOP \>21 mmHg with or without anti-glaucoma medication;
. Obvious glaucomatous optic neuropathy (cup-to-disc \[C/D\] ratio≥0.7, or C/D asymmetry \> 0.2, or the rim width at the superior and inferior temporal \< 0.1 vertical diameters of optic disc);
. With glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer using SITA-Standard 24-2 or 30-2 algorithm; mean deviation ≤ -12dB;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two different surgeries — phacotrabeculectomy and phacogoniotomy — for advanced angle-closure glaucoma; which of these procedures does my doctor think would be more appropriate for my specific stage and type of glaucoma?
2Since the trial is no longer recruiting, could my doctor explain what results or safety data have emerged so far, and whether those findings might influence which surgical approach they'd recommend for me?
3The trial's main goal is measuring changes in eye pressure — how much of a pressure reduction would my doctor consider meaningful or successful for my situation, and how do the two surgeries typically compare on that front?
4Trabeculectomy is a more established glaucoma surgery while goniotomy is a newer minimally invasive approach — given that this is an advanced-stage disease, does my doctor feel the evidence is strong enough to choose one over the other, or is standard care with one of these procedures already a clearer option for me?
5What would the recovery and follow-up demands look like for each of the two surgeries being studied, and are there practical differences in risk or lifestyle impact that my doctor thinks I should weigh before considering either one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Clinically obvious cataract and uncorrected visual acuity (UCVA) \<0.63 (Early Treatment Diabetic Retinopathy Study, \[ETDRS\] chart), or need lens extraction assessed by a clinician;
. Voluntarily participate in study and provide signed informed consent.