Last updated: June 9, 2022
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Glaucoma
Treatment
N/AClinical Study ID
NCT05163951
2021KYPJ191
Ages 45-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 45-80 years.
- Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b,and d:
- PAS: ≥180° range, including nasal and inferior quadrants;
- IOP >21 mmHg with or without anti-glaucoma medications (the medications includethe maximally tolerated medications), taken with the Goldmann applanationtonometer;
- Glaucomatous optic neuropathy (cup-to-disc [C/D] ratio ≥0.7, C/D asymmetry >0.2,or rim width at the superior and inferior temporal areas <0.1 of the verticaldiameters of the optic disc);
- Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentralscotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB).
- No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment DiabeticRetinopathy Study chart);
- Axial length of ≥20 mm.
Exclusion
Exclusion Criteria:
- History of ocular surgery or trauma.
- Retinal disease that influences the collection of ocular parameters or other types ofglaucoma, including open-angle glaucoma, secondary angle-closure glaucoma, steroidalglaucoma, angle recession glaucoma, neovascular glaucoma, nanophthalmos, andpseudoexfoliation syndrome.
- Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye).
- An International Standardized Ratio of >3.0, for patients receiving warfarin oranticoagulant therapy before surgery.
- Patients with serious systemic diseases.
- Pregnant or lactating women. If both eyes are eligible for the study, the eye with the worse visual field or optic nervewill be included.
Study Design
Total Participants: 88
Study Start date:
January 05, 2022
Estimated Completion Date:
June 30, 2026
Study Description
Connect with a study center
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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