Trial Outcomes & Findings for Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) (NCT NCT01540370)
NCT ID: NCT01540370
Last Updated: 2013-09-19
Results Overview
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.
COMPLETED
102 participants
Day 1
2013-09-19
Participant Flow
Participant milestones
| Measure |
Patients With OAG and/or OHT
Patients with OAG and/or OHT.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT)
Baseline characteristics by cohort
| Measure |
Patients With OAG and/or OHT
n=102 Participants
Patients with OAG and/or OHT.
|
|---|---|
|
Age Continuous
|
64.1 Years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)
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.
Outcome measures
| Measure |
Patients With OAG and/or OHT
n=100 Participants
Patients with OAG and/or OHT.
|
|---|---|
|
Intra- Examiner Agreement in Angle Width by Goniometric Lens
|
0.88 Kappa statistics
|
PRIMARY outcome
Timeframe: Day 1Population: Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)
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.
Outcome measures
| Measure |
Patients With OAG and/or OHT
n=100 Participants
Patients with OAG and/or OHT.
|
|---|---|
|
Inter- Examiner Agreement in Angle Width by Goniometric Lens
|
0.72 Kappa statistics
Interval 0.51 to 0.85
|
Adverse Events
Patients With OAG and/or OHT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER