Status:
RECRUITING
Evaluation of Phacogoniotomy in Medically-controlled POAG
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
West China Hospital
Chongqing Medical University
Conditions:
Glaucoma, Open-Angle
Cataract Complicated
Eligibility:
All Genders
40-85 years
Phase:
NA
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...
Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma (POAG) remaining the most common subtype. Although there are various methods to treat POAG, medicat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Axial length \> 28 mm.
- Monophthalmia (best-corrected visual acuity of the non-study eye \< 0.01).
- Coexistence of severe systemic diseases affecting the entire body.
- Pregnant or lactating women.
- If both eyes of a patient meet the criteria, the eye with worse visual acuity will be selected for inclusion.
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06201455
Start Date
September 28 2023
End Date
December 31 2029
Last Update
December 11 2024
Active Locations (1)
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1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060