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NCT01781962 Clinical Trial

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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01781962
Other study ID # 192024-077
Secondary ID
Status Terminated
Phase N/A
First received January 30, 2013
Last updated July 30, 2014
Start date January 2013
Est. completion date June 2013

Study information
Verified date July 2014
Source Allergan
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 206
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Of Chinese descent

- Open-angle Glaucoma or Ocular Hypertension in each eye

Exclusion Criteria:

- History of a narrow-angle or angle closure glaucoma

- Angle abnormalities in either eye

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• No Treatment
No Treatment was given in this study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) 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. Day 1 No
Secondary Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens 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. Day 1 No
Secondary Number of Study Eyes in Each Step Grade Using Gonioscopic Lens 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. Day 1 No
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