Last updated: February 10, 2022
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Glaucoma
Open Angle Glaucoma
Treatment
N/AClinical Study ID
NCT04155164
2019KYPJ130
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 18-65 years old;
- The baseline value of intraocular pressure ≤ 21 mmHg in either eye whether untreatedor treated by ≤ 2 eye drops (laser or filtering surgery should be performed over 3months).
- Over two times of experience of visual field examination (24-2 or 30-2 visual fieldexaminations) in the past two years, or false positive/false negative ratio less than 33%;
- Diagnosed POAG by Glaucoma specialists from Zhongshan Ophthalmic Center with openangle, and impairment in optic disc or visual field in one or both eyes.
- Patient is at risk of glaucomatous progression, as determined by the documentedpresence of optic disc hemorrhage within 12 months in either eye, OR ≥2 of thefollowing risk factors:
- Vertical cup-to-disc ratio >0.8 in one or both eyes
- Mean deviation in visual field worse than <10 dB in either eye (verified by thereading center)
- Pseudoexfoliation in either eye
- Family history (parent or sibling) of glaucoma
- Hypertension
- Systemic hypertension requiring medical treatment Migraine (defined by theInternational Headache Society with or without aura, Raynaud's syndrome, or both:
- The main organs are functioning normally and meet the following criteria:
- Blood sample should meet the following criteria: (no blood transfusion within 14days) A. Hemoglobin (> 90g/L); B. Platelet count (>105*10e9/L)
- Biochemical and urinary examinations should meet the following criteria:
- . Urine bilirubin < 1.25 times ULN (Upper Limit of Normal);
- . ALT and AST < 2.5 times ULN;
- . CREA ≤ ULN;
Exclusion
Exclusion criteria:
- Secondary open-angle glaucoma (such as pigmentation syndrome, trauma, etc.) orangle-closure glaucoma.
- The best corrected visual acuity of either eye is less than 6/36;
- The mean derivation of visual field in either eye is less than - 22dB.
- Use of >2 topical (or any oral) IOP-lowering products at the baseline visit.
- Any ocular pathology in either eye that may have interfered with the ability to obtainvisual field, disc imaging, or accurate IOP readings such as uveitis, refractiveopacification;
- Eye drops such as neuroprotective therapies have been used in the past three weeksmight affect this clinical study, for inclusion need 8 weeks of wash period.
- Pregnant or nursing women;
- Diabetes mellitus, definite impairment of liver and kidney function, or severe heart,liver or kidney diseases;
- In the last three months, ophthalmic surgery (including cataract surgery) has beenperformed
- Enrolled in other clinical study at the same time.
- Could not complete the study according to the requirements in this research .
- History of epilepsy or severe mental illness, including schizophrenia, bipolardisorder or severe depression
Study Design
Total Participants: 40
Study Start date:
December 10, 2019
Estimated Completion Date:
May 31, 2024
Study Description
Connect with a study center
Zhongshan Ophthalmic Center
Guangzhou, Guangdong 510000
ChinaActive - Recruiting
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