Status:
ACTIVE_NOT_RECRUITING
Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
The Second Affiliated Hospital of Harbin Medical University
West China Hospital
Conditions:
Glaucoma, Angle-Closure
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced pri...
Detailed Description
Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method i...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Aged 40-80 years;
- Diagnosed with advanced PACG: meet with (1) (2) (3) or (1) (2) (4)
- At least 180-degree PAS under gonioscopy and it should cover the nasal and inferior quadrants for surgical purposes;
- IOP \>21 mmHg with or without anti-glaucoma medication;
- Obvious glaucomatous optic neuropathy (cup-to-disc \[C/D\] ratio≥0.7, or C/D asymmetry \> 0.2, or the rim width at the superior and inferior temporal \< 0.1 vertical diameters of optic disc);
- With glaucomatous visual field defects, such as nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer using SITA-Standard 24-2 or 30-2 algorithm; mean deviation ≤ -12dB;
- Clinically obvious cataract and uncorrected visual acuity (UCVA) \<0.63 (Early Treatment Diabetic Retinopathy Study, \[ETDRS\] chart), or need lens extraction assessed by a clinician;
- Voluntarily participate in study and provide signed informed consent.
- Exclusion criteria a. History of ocular surgery (other than laser iridotomy or laser iriplasty) or trauma; b. With other types of glaucoma; (i.e. open angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle regression glaucoma, neovascular glaucoma, nanophthalmos, pseudoexfoliation syndrome) c. The International Standardized Ratio \> 3.0 for patients receiving warfarin or anticoagulant therapy before surgery; d. With retinal disease that affects the collection of ocular parameters; f. Monophthalmia (best-corrected visual acuity \[BCVA\] \<0.01 in the non-study eye); g. With other serious systemic diseases; h. Pregnant or lactating women \* If both eyes are eligible for the study, the eye with the worse UCVA will be recruited.
Exclusion
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT04878458
Start Date
May 31 2021
End Date
June 30 2025
Last Update
December 11 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
2
Zhongshan Ophthalmic Center
Guangdong, China