A Study of Quantitative Assessments of Angle Width in Chinese Patients With Open-angle Glaucoma and/or Ocular Hypertension

Terminated

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Other: No Treatment

• Registration Number: NCT01781962
• Lead Sponsor: Allergan

Brief Summary

This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-30
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2014-06-16
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-30
• Last Update Submitted: 2014-07-30
• Results First Posted: 2014-07-31
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Of Chinese descent
• Open-angle Glaucoma or Ocular Hypertension in each eye

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Exclusion Criteria

• History of a narrow-angle or angle closure glaucoma
• Angle abnormalities in either eye

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	No Treatment	Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.

Primary Outcome Measures

Name	Time	Method
Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT)	Day 1	The angle width formed between the eye's cornea and iris in both eyes was measured in microns (µm) using AS OCT, a laser-based, noninvasive, diagnostic system providing high-resolution images of the eye.

Secondary Outcome Measures

Name	Time	Method
Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens	Day 1	The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Shaffer grading where: grade 4=wide open, grade 3=moderately open, grade 2=moderately narrow, grade 1=very narrow or grade 0=closed. The number of eyes in each Shaffer Grade is reported.
Number of Study Eyes in Each Step Grade Using Gonioscopic Lens	Day 1	The angle width formed between the cornea and iris in both eyes was measured by gonioscopy using Large Step Grading ranging from 1.0 (smallest angle width) to 7.5 (largest angle width) with 0.5 unit intervals where each Large Step unit represented a fixed length of approximately 200 µm. The number of eyes in each Large Step Grade is reported.