NCT06201455 Evaluation of Phacogoniotomy in Medically-controlled POAG
| NCT ID | NCT06201455 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Glaucoma, Open-Angle |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-28 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-09-28 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06201455 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Glaucoma, Open-Angle. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06201455 currently recruiting?
Yes, NCT06201455 is actively recruiting participants. Contact the research team at zhangxl2@mail.sysu.edu.cn for enrollment information.
Where is the NCT06201455 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06201455 clinical trial?
NCT06201455 is sponsored by Sun Yat-sen University. The trial plans to enroll 100 participants.