ACTRN12618000453280
Recruiting
未知
Progressive retinal nerve fiber layer (RNFL) thinning as a biomarker to guide intraocular pressure (IOP) lowering treatment in ocular hypertensives (OHT)
Prof Leung Kai Shun Christopher0 sites310 target enrollmentMarch 28, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Prof Leung Kai Shun Christopher
- Enrollment
- 310
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) age more than or equal to 18 years;
- •2\) best corrected VA is greater than or equal to 20/40
- •3\) an average IOP is more than or equal to 23mmHg but less than 32mmHg in at least 1 eye an more than or equal to 21mmHg but less than 32mmHg in the fellow eye measured from 3 separate baseline visits within 6 months
- •4\) gonioscopically open anterior chamber angles
- •5\) 3 reliable VF results without VF defects, normal optic disc and RNFL configuration in clinical examination
- •6\) no RNFL abnormalities(i.e. within the 95% normal ranges) in the OCT RNFL thickness deviation map
- •7\) no prior history of surgical/laser procedure for IOP lowering and receiving no topical IOP\-lowering medication.
- •8\) IOP measurements for eligibility assessment are obtained after washout of prestudy topical IOP
Exclusion Criteria
- •1\) secondary causes of elevated IOP;
- •2\) ocular or systemic diseases that may cause VF loss or optic disc abnormalities
- •3\) high myopia (spherical error\<\-6\.0D)
- •4\) inability to perform reliable VF; suboptimal quality of SDOCT images
- •5\) previous intraocular surgery other than uncomplicated cataract extraction
- •6\) diabetic retinopathy/maculopathy.
Outcomes
Primary Outcomes
Not specified
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