Actively Recruiting
Evaluation of Phacogoniotomy in Medically-controlled POAG
Led by Sun Yat-sen University · Updated on 2024-12-11
100
Participants Needed
1
Research Sites
326 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
W
West China Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Phacogoniotomy in Medically-controlled POAG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 85 years, any gender
- Diagnosed with primary open-angle glaucoma (POAG)
- Intraocular pressure controlled under 1 to 4 topical hypotensive medications, IOP c= 24 mmHg
- Mean deviation for visual field test e= -16 dB
- Presence of clinically significant cataract and best-corrected visual acuity c= 0.63 on ETDRS chart
- Voluntary participation with informed consent and agreement to follow-up visits according to protocol
You will not qualify if you...
- Any history of intraocular surgery or eye trauma
- Other types of glaucoma such as primary angle-closure glaucoma or secondary glaucoma (including pigmentary, steroid-induced, angle-recession, neovascular, inflammatory, pseudoexfoliation syndrome)
- Severe eye diseases affecting eye measurements or visual field testing
- Axial eye length greater than 28 mm
- Monophthalmia with best-corrected visual acuity of non-study eye less than 0.01
- Severe systemic diseases affecting the whole body
- Pregnant or breastfeeding women
- If both eyes qualify, only the eye with worse vision is included
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiulan Zhang, MD. PhD
CONTACT
Y
Yunhe Song, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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