Evaluation of Phacogoniotomy in Medically-controlled POAG

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorSun Yat-sen University

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

100 Participants
are divided into 2 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