About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PEI+GT
- PEI+MED
Treatment groups
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor institution
West China Hospital
Collaborator
Chongqing Medical University
Collaborator
The Second Hospital of Anhui Medical University
Collaborator
Handan City Eye Hospital
Collaborator
Shijiazhuang People's Hospital
Collaborator
Chengdu First People's Hospital
Collaborator
Guangdong Hospital of Traditional Chinese Medicine, Zhuhai
Collaborator
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Collaborator
Huizhou Municipal Central Hospital
Collaborator