Comparing two treatments for glaucoma with cataract

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

This study is testing whether a new surgery for glaucoma combined with cataract removal works as well as the usual surgery plus eye drops for people with both conditions.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06201455 on ClinicalTrials.gov

What this trial studies

This multicenter randomized controlled trial aims to evaluate the effectiveness of phacoemulsification with goniotomy (PEI+GT) versus phacoemulsification with medical therapy (PEI+MED) in patients with medically-controlled primary open-angle glaucoma (POAG) and cataract. Participants will be randomly assigned to receive either treatment and will be followed for one year to assess intraocular pressure reduction and health economics. The study seeks to determine if the minimally invasive approach of PEI+GT is as effective as the traditional medical therapy while potentially offering benefits in terms of recovery and complications.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 to 85 diagnosed with medically-controlled primary open-angle glaucoma and cataract.

Not a fit: Patients with a history of intraocular surgery, other types of glaucoma, or severe ocular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with glaucoma and cataract, reducing their reliance on medication.

How similar studies have performed: Previous studies have shown promising results for minimally invasive glaucoma surgeries, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

1. 40 ≤ Age ≤ 85 years, gender unrestricted.
2. Diagnosed with POAG.
3. Controlled IOP under 1 to 4 topical hypotensive medications, IOP ≤ 24 mmHg
4. Mean deviation (MD) for perimetry ≥ -16dB.
5. Presence of clinically significant cataract and best-corrected visual acuity measured using the ETDRS chart ≤ 0.63.
6. 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:

1. Any history of intraocular surgery or ocular trauma.
2. 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).
3. Presence of severe ocular diseases of various types that affect the acquisition of ocular parameters or interfere with perimetry.
4. Axial length \> 28 mm.
5. Monophthalmia (best-corrected visual acuity of the non-study eye \< 0.01).
6. Coexistence of severe systemic diseases affecting the entire body.
7. 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 this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Xiulan Zhang, MD. PhD

Conditions: Glaucoma, Open-Angle, Cataract Complicated, Goniotomy, Cataract, Minimally invasive glaucoma surgery