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

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ClinicalTrials.gov Identifier: NCT01781962
Recruitment Status : Terminated (Study terminated due to corporate decision.)
First Posted : February 1, 2013
Results First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Open-angle Glaucoma Ocular Hypertension Other: No Treatment

Study Type : Observational
Actual Enrollment : 206 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Group/Cohort Intervention/treatment
All Participants
Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
Other: No Treatment
No Treatment was given in this study.



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



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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

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

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01781962     History of Changes
Other Study ID Numbers: 192024-077
First Posted: February 1, 2013    Key Record Dates
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