Evaluation of Phacogoniotomy in Medically-controlled POAG (NCT06201455) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Phacogoniotomy in Medically-controlled POAG
China100 participantsStarted 2023-09-28
Plain-language summary
The goal of this multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with cataract. The main questions it aims to answer are:
* Whether the PEI+GT was non-inferior to PEI+MED with regard to the intraocular pressure lowering effect in medically-controlled POAG.
* Whether the PEI+GT has value of health economics. Participants will be randomized to receive either PEI+GT or PEI+MED, and followed up with a 1-year period as a primary outcome.
Who can participate
Age range
40 Years – 85 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
. 40 ≤ Age ≤ 85 years, gender unrestricted.
. Diagnosed with POAG.
. Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg
. Mean deviation (MD) for perimetry ≥ -16dB.
. Presence of clinically significant cataract and best-corrected visual acuity measured using the ETDRS chart ≤ 0.63.
. Voluntary participation of the patient in this study, signing an informed consent form, and agreeing to follow-up visits according to the study protocol.
Exclusion criteria
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. Any history of intraocular surgery or ocular trauma.
. Presence of other types of glaucoma, including primary angle-closure glaucoma and various forms of secondary glaucoma (e.g. secondary angle-closure, pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, and pseudoexfoliation syndrome).
. Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
. Axial length \> 28 mm.
. Monophthalmia (best-corrected visual acuity of the non-study eye \< 0.01).
. Coexistence of severe systemic diseases affecting the entire body.