Glaucoma, Open-AngleNCT01540370

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

An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open-Angle, Ocular Hypertension
What is being tested?: No Treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Feb 2012to Jul 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with open-angle glaucoma and/or ocular hypertension

Who may be able to join

Open-angle glaucoma or ocular hypertension

Who cannot join

Allergy or sensitivity to diagnostic agents used in study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Rochester, New York

Other trials in United States

About this study

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).

Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Being tested: No Treatment
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No TreatmentOther
No treatment

Study groups in NCT01540370
Study group	Role	What they receive
Patients with OAG and/or OHT		Patients with OAG and/or OHT Receives: Other: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1
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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Jul 2012

First posted28 Feb 2012 (estimated)
Study startFeb 2012
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01540370
Sponsor's protocol ID: 192024-076
Status last verified: Jul 2013
First submitted: 23 Feb 2012
Last updated: 19 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma, Open-Angle trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT)
ClinicalTrials.gov ID: NCT01540370
Acronym / sponsor ID: 192024-076
Conditions: Glaucoma, Open-Angle, Ocular Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 28 Feb 2012 (estimated)
Results: Posted 19 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with OAG and/or OHT	–	Other: No TreatmentPatients with OAG and/or OHT

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with open-angle glaucoma and/or ocular hypertension

Key inclusion criteria (1 listed)

Open-angle glaucoma or ocular hypertension

Key exclusion criteria (1 listed)

Allergy or sensitivity to diagnostic agents used in study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No TreatmentNo treatment	Other	Patients with OAG and/or OHT

Primary outcome

Intra- Examiner Agreement in Angle Width by Goniometric Lens
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 19 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With OAG and/or OHT	102	100

Primary outcome: Intra- Examiner Agreement in Angle Width by Goniometric Lens

Time frame: Day 1. Number. Unit: Kappa statistics

Measure	Patients With OAG and/or OHT n = 100
Value	0.88

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

Primary outcome: Inter- Examiner Agreement in Angle Width by Goniometric Lens

Time frame: Day 1. Number. Unit: Kappa statistics

Measure	Patients With OAG and/or OHT n = 100
Value	0.72 (0.51 to 0.85)

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

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With OAG and/or OHT	0 of 101 (0%)	0 of 101 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, Open-Angle and Ocular Hypertension, run by Allergan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra- Examiner Agreement in Angle Width by Goniometric Lens (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01540370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.