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

Completed

• Conditions: Glaucoma, Open-Angle; Ocular Hypertension
• Interventions: Other: No Treatment

• Registration Number: NCT01540370
• Lead Sponsor: Allergan

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-02-28
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-07
• Results First Submitted: 2013-07-16
• Results First Submitted QC: 2013-07-16
• Last Update Submitted: 2013-07-16
• Results First Posted: 2013-09-19
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Open-angle glaucoma or ocular hypertension

Exclusion Criteria

• Allergy or sensitivity to diagnostic agents used in study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with OAG and/or OHT	No Treatment	Patients with OAG and/or OHT

Primary Outcome Measures

Name	Time	Method
Intra- Examiner Agreement in Angle Width by Goniometric Lens	Day 1	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	Day 1	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.