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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01540370
• Other study ID #: 192024-076
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: July 16, 2013
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

• Allergy or sensitivity to diagnostic agents used in study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Other:
• No Treatment
No treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra- Examiner Agreement in Angle Width by Goniometric Lens	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.	Day 1	No
Primary	Inter- Examiner Agreement in Angle Width by Goniometric Lens	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.	Day 1	No