RecruitingNot ApplicableNCT06201455

Evaluation of Phacogoniotomy in Medically-controlled POAG

Efficacy of Phacogoniotomy in Medically-controlled Primary Open-angle Glaucoma With Cataract a Multicenter Non-inferiority Randomized Controlled Trial

Sponsor

Sun Yat-sen University

Enrollment

100 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Glaucoma, Open-Angle Cataract Complicated Goniotomy

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.

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Inclusion Criteria6

≤ 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 Criteria8

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.

Interventions

PROCEDUREPEI+GT

After a standard phacoemulsification with intraocular lens implantation (PEI) is performed. The viscoelastic substance will be injected into the anterior chamber again to maintain corneal rigidity. The surgical microscope will be adjusted to tilt 35-40° towards the patient's nasal side, and the patient's head position will be adjusted to tilt 35-40° accordingly. A viscoelastic substance will be applied to the corneal surface to facilitate direct visualization of the angle structures under a gonioscope. The Tanito Microhook will be inserted through the main incision into the anterior chamber, and under gonioscopic guidance, the nasal (or inferonasal) trabecular meshwork and the inner wall of Schlemm's canal will be incised, approximately 120° in extent (60° in each direction).

PROCEDUREPEI+MED

Participants assigned to control group will undergo routine PEI surgery. Postoperatively, the decision to administer anti-glaucoma medication is based on intraocular pressure (IOP) measurements, and the target IOP is set at 16 mmHg. The selection of medications is informed by the Asia Pacific Glaucoma Guidelines (Kugler Publications, 2016), while the target IOP reference is the European Glaucoma Guidelines.