Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01540370
First received: February 23, 2012
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

This study will evaluate assessments from the Goniometric Lens compared with those from anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular hypertension (OHT).


Condition Intervention
Glaucoma, Open-Angle
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:
  • Intra- Examiner Agreement in Angle Width by Goniometric Lens [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Intra-rater agreement (for each of the 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.

  • Inter- Examiner Agreement in Angle Width by Goniometric Lens [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Inter-rater agreement (among 6 raters) of Large Step angle width (range: 0.5 to 5.5 with 0.5 unit intervals) was evaluated using weighted kappa (Fleiss-Cohen) statistics. The angle is the area between the iris and cornea of the eye. Each examiner performed a pair of angle-width measurements by goniometric lens predilation (ie, 2 measurements per examiner). The degree of agreement within raters was interpreted according to Landis and Koch, where: <0:poor, 0.00-0.20:slight, 0.21-0.40:fair, 0.41-0.60:moderate, 0.61-0.80:substantial, and 0.81-1.00:almost perfect.


Enrollment: 102
Study Start Date: February 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with OAG and/or OHT
Patients with OAG and/or OHT
Other: No Treatment
No treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with open-angle glaucoma and/or ocular hypertension

Criteria

Inclusion Criteria:

  • Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Allergy or sensitivity to diagnostic agents used in study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01540370

Locations
United States, New York
Rochester, New York, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01540370     History of Changes
Other Study ID Numbers: 192024-076
Study First Received: February 23, 2012
Results First Received: July 16, 2013
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014