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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01540370
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 20.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Other: No Treatment

Study Design

• Study Type: Observational
• Actual Enrollment: 102 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Patients with OAG and/or OHT Patients with OAG and/or OHT	Other: No Treatment; No treatment

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

• Allergy or sensitivity to diagnostic agents used in study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Rochester	New York	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01540370
• Other Study ID Numbers: 192024-076
• First Posted: Feb 28, 2012
• Last Update Posted: Sep 19, 2013
• Last Verified: Jul 1, 2013

• Additional relevant MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension

Study Results

Participant Flow

Arm/Group Title	Patients With OAG and/or OHT
Arm/Group Description	Patients with OAG and/or OHT.
Period Title: Overall Study
STARTED	102
COMPLETED	100
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Patients With OAG and/or OHT
Arm/Group Description	Patients with OAG and/or OHT.
Overall Participants	102
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	64.1 (12.18)
Sex: Female, Male (Count of Participants)
Female	53 52%
Male	49 48%

Outcome Measures

1. Primary Outcome

Title	Intra- Examiner Agreement in Angle Width by Goniometric Lens
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)

Arm/Group Title	Patients With OAG and/or OHT
Arm/Group Description	Patients with OAG and/or OHT.
Measure Participants	100
Number [Kappa statistics]	0.88

2. Primary Outcome

Title	Inter- Examiner Agreement in Angle Width by Goniometric Lens
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)

Arm/Group Title	Patients With OAG and/or OHT
Arm/Group Description	Patients with OAG and/or OHT.
Measure Participants	100
Number [Kappa statistics]	0.72

Adverse Events

Adverse Event Reporting Description	The Safety Population is used to assess all Serious Adverse Events (SAEs) and Adverse Events (AEs). The Safety Population includes all enrolled patients who have been examined in the study eye.
Arm/Group Title	Patients With OAG and/or OHT
Arm/Group Description	Patients with OAG and/or OHT.
All Cause Mortality
	Patients With OAG and/or OHT
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patients With OAG and/or OHT
	Affected / at Risk (%)	# Events
Total	0/101 (0%)
Other (Not Including Serious) Adverse Events
	Patients With OAG and/or OHT
	Affected / at Risk (%)	# Events
Total	0/101 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.