Evaluation of Phacogoniotomy in Medically-controlled POAG
Recruiting · NCT06201455 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
- 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.
- Pregnant or lactating women.
- If both eyes of a patient meet the criteria, the eye with worse visual acuity will be selected for inclusion.
Where it is running
1 location listed.
- Zhongshan Ophthalmic Center, Sun Yat-sen University - Guangzhou, Guangdong, China