Progressive retinal nerve fiber layer (RNFL) thinning as a biomarker to guide intraocular pressure (IOP) lowering treatment in ocular hypertensives (OHT)

Not Applicable

Recruiting

• Conditions: Retinal Nerve Fiber Layer Thinning; ocular hypertension; Eye - Normal eye development and function; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12618000453280
• Lead Sponsor: Prof Leung Kai Shun Christopher

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-28
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 310

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified