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 range40 Years – 85 Years
SexALL
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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
✕. 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.