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

This study has been terminated.
(Study terminated due to corporate decision.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781962
First Posted: February 1, 2013
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
This study will assess angle width in Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension.

Condition Intervention
Open-angle Glaucoma Ocular Hypertension Other: No Treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Anterior Angle Width Using Anterior Segment Optical Coherence Tomography (AS OCT) [ Time Frame: 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:
  • Number of Study Eyes in Each Shaffer Grade Using Gonioscopic Lens [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 206
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All Participants
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
Other: No Treatment
No Treatment was given in this study.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese patients with Open-angle Glaucoma and/or Ocular Hypertension
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781962


Locations
China
Beijing, China
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01781962     History of Changes
Other Study ID Numbers: 192024-077
First Submitted: January 30, 2013
First Posted: February 1, 2013
Results First Submitted: June 16, 2014
Results First Posted: July 31, 2014
Last Update Posted: July 31, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases