Glaucoma, Open-Angle, Ocular Hypertension
Conditions
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).
Interventions
OTHERNo Treatment
No treatment
Sponsors
Allergan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open-angle glaucoma or ocular hypertension
Exclusion criteria
* Allergy or sensitivity to diagnostic agents used in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With OAG and/or OHT Patients with OAG and/or OHT. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Patients With OAG and/or OHT |
|---|---|
| Age Continuous | 64.1 Years STANDARD_DEVIATION 12.18 |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 101 |
| serious Total, serious adverse events | 0 / 101 |
Outcome results
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.
Time frame: Day 1
Population: Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With OAG and/or OHT | Inter- Examiner Agreement in Angle Width by Goniometric Lens | 0.72 Kappa statistics |
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.
Time frame: Day 1
Population: Modified Intent to Treat: enrolled patients with unobstructed and measurable inferior angles by goniometric reading and anterior segment optical coherence tomography (OCT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With OAG and/or OHT | Intra- Examiner Agreement in Angle Width by Goniometric Lens | 0.88 Kappa statistics |