Evaluation of Phacogoniotomy in Medically-controlled POAG

Launched by SUN YAT-SEN UNIVERSITY · Jan 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with primary open-angle glaucoma (POAG) who also have cataracts. Specifically, the study is comparing two methods: one that uses a surgical procedure called goniotomy along with cataract surgery (called phacoemulsification with intraocular lens implantation) and another that combines cataract surgery with medication. The main goal is to see if the surgical approach is just as effective as the medication in lowering eye pressure, which is crucial for managing glaucoma.

To participate in this trial, individuals must be between 40 and 85 years old, have been diagnosed with POAG, and currently have their eye pressure controlled with up to four different medications. Participants will be randomly assigned to one of the two treatment groups and will be monitored for one year to assess the outcomes. This study is open to all genders, and it’s taking place at multiple locations. If you’re interested, you’ll need to provide informed consent and attend follow-up visits as part of the study.

Gender

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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.