NCT06201455Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 27 Aug 2023
- Start date
- 28 Sept 2023
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Glaucoma
- NCT number
- NCT06201455
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 28 Sept 2023 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Coexistence of severe systemic diseases affecting the entire body.
Other
- Axial length \> 28 mm.
- Monophthalmia (best-corrected visual acuity of the non-study eye \< 0.01).
- Pregnant or lactating women.
- If both eyes of a patient meet the criteria, the eye with worse visual acuity will be selected for inclusion.
Who the study is looking for
- 40 ≤ 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.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Ophthalmic Center,Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.