HealthyNorm-Oct900NCT01518686
Age-related Normative Values for the Octopus 900 Perimeter
A study testing Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland) in people with Healthy, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to determine normal values of the visual field (VF), corrected for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic perimetry (SKP). Read more about this study
- Who is it for?
- Ages 11 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 79 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- maximum spherical ametropia ± 6 Diopters (D)
- maximum cylindrical ametropia ± 2 D
- distant visual acuity ≥ 1.0 logMAR [20/20] for subjects up to 60 years, ≥ 0.8 logMAR [20/25] for subjects from 61-70 years, ≥ 0.63 logMAR [20/30] for subjects older than 70 years
- isocoria, pupil diameter > 3mm
- intraocular pressure (air pulse tonometer) ≤ 21mmHg
- normal anterior segments
- ocular fundus: normal appearance of the cup to disc ratio (CDR) ≤ 0.5, interocular difference of CDR < 0.3
- normal macular region, vessels, and peripheral retinal examination (with undilated pupils).
Who cannot join
- amblyopia
- strabismus
- ocular motility disorder
- diseases of the retina
- glaucoma, glaucoma suspect
- macular degeneration
Show all 26Show fewer
- IOP > 21 mmHg
- abnormal color vision test (ISPP - Ishihara and Standard Pseudoisochromatic Plates = SPP)
- history or findings of other neuro-ophthalmological disease
- relevant opacities of the central refractive media (cornea, lens, vitreous body)
- use of miotic drugs
- intraocular surgery (except uncomplicated cataract surgery, more than three months previous to testing)
- kerato-refractive surgery (LASIK)
- drugs influencing reaction time
- drugs indicating severe general diseases (anti-diabetic pharmaceuticals and anti-hypertensive medication were allowed for subjects older than 70 years)
- mental diseases (for example psychosis)
- pregnancy, nursing
- acute infections
- heavy smoking (>10 cigarettes /day)
- alcohol abuse
- diabetic retinopathy
- coronary heart disease
- stroke
- migraine
- Raynaud's syndrome
- suspected lack of compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Normal Values for the Full Visual Field, Corrected for Age- and Reaction Time, Using Semi-automated Kinetic Testing on the Octopus 900 Perimeter
The purpose of this study is to determine normal values of the visual field (VF), corrected for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic perimetry (SKP).
- Conditions
- Healthy
- Being tested
- Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)
- Keywords
- Norm values, semi-automated kinetic perimetry, isopters, mathematical model, luminance, test-retest reliability, deviation, age dependance, different age groups, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)Device
We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s .
The peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian)
| Study group | Role | What they receive |
|---|---|---|
| one arm | No intervention | observational study, no cohort, single group of different ages Receives: Device: Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the full Visual Field using semi-automated kinetic perimetry.
additional a subgroup of 14 participants were tested at 3 separate sessions within 4 weeks.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startJun 2006
- Primary completionMar 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Haag-Streit AG
- Responsible party
- Principal investigator, Ulrich Schiefer, University Hospital Tuebingen
- Investigators
- Ulrich Schiefer, Prof. Dr. med., Principal investigator, Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518686
- Sponsor's protocol ID
- 217/2006 local review board
- Acronym
- Norm-Oct900
- Status last verified
- Dec 2013
- First submitted
- 12 Jan 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values for the Full Visual Field, Corrected for Age- and Reaction Time, Using Semi-automated Kinetic Testing on the Octopus 900 Perimeter
- ClinicalTrials.gov ID
- NCT01518686
- Acronym / sponsor ID
- Norm-Oct900 / 217/2006 local review board
- Conditions
- Healthy
- Keywords
- Norm values, semi-automated kinetic perimetry, isopters, mathematical model, luminance, test-retest reliability, deviation, age dependance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Haag-Streit AG
- Study start
- Jun 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine normal values of the visual field (VF), corrected for age- and reaction time (RT) using the Octopus 900 perimeter and semi-automated kinetic perimetry (SKP).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | No intervention | Device: Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)observational study, no cohort, single group of different ages |
Who may qualify
- Ages
- 11 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- maximum spherical ametropia ± 6 Diopters (D)
- maximum cylindrical ametropia ± 2 D
- distant visual acuity ≥ 1.0 logMAR [20/20] for subjects up to 60 years, ≥ 0.8 logMAR [20/25] for subjects from 61-70 years, ≥ 0.63 logMAR [20/30] for subjects older than 70 years
- isocoria, pupil diameter > 3mm
- intraocular pressure (air pulse tonometer) ≤ 21mmHg
Key exclusion criteria (26 listed)
- amblyopia
- strabismus
- ocular motility disorder
- diseases of the retina
- glaucoma, glaucoma suspect
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 |
|---|---|---|
| Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s . The peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian) | Device | one arm |
Primary outcome
Measurement of the full Visual Field using semi-automated kinetic perimetry.
Time frame: one day
additional a subgroup of 14 participants were tested at 3 separate sessions within 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Ulrich Schiefer, Prof. Dr. med. principal investigator
Centre for Ophthalmology / Institute for Ophthalmic Research, University of Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland) in people with Healthy, run by University Hospital Tuebingen at 1 site in Germany.
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 8 inclusion and 26 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 11 Dec 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of the full Visual Field using semi-automated kinetic perimetry. (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2013.