Comparing two treatments for glaucoma with cataract

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongshan Ophthalmic Center, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Xiulan Zhang, MD. PhD
• Email: zhangxl2@mail.sysu.edu.cn
• Phone: +86 13570166308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.