Homonymous HemianopiaHemi-DriveNCT01372332

Assessment of Homonymous Visual Loss and Its Impact on Visual Exploration, Activities of Daily Living (ADL) and Quality of Life (QoL)

An observational study of Homonymous Hemianopia, run by University Hospital Tuebingen at 1 site in Germany.

Completed

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

Trial summary

The purpose of this explorative study, targeting subjects with homonymous visual field loss, is threefold: (i) to identify the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score, using a validated questionnaire (NEI-VFQ 25) (ii) to determine… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Homonymous Hemianopia
How many people: 60 participants
Where: 1 siteGermany
Study dates: Jun 2011to Apr 2013
Phase: Observational
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: 30 patients with homonymous visual field defects and 30 age-related (+ 5 years of age) and gender-matched normal subjects. All subjects are free to stop participation of the tests at any time without any consequences on the future treatment of the patient. The circumstances of any discontinuation will be documented.

Who may be able to join

Patients with homonymous visual field defects Primary inclusion criterion: (Stable) homonymous visual field defects, as obtained by binocular semi-automated kinetic perimetry (SKP), using the III4e stimulus, within on onset of at least six months ago, due to a vascular or a traumatic lesion.
Further inclusion criteria: (i) general: physical, intellectual and linguistic abilities, necessary to understand the test requirements: no mobility limitations / hemiparesis, Minimental Status Examination Test score above 24, adequate knowledge of the German language, willingness to comply with the protocol, > 18 years, informed consent.
Ophthalmological: spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt, best corrected distant visual acuity > 6/12 (= 0.5), isocoria, pupil diameter > 3 mm, intraocular pressure ≤ 21 mmHg, normal anterior segments, no clinically relevant media opacities, normal appearance of the optic disc (cup to disc ratio = CDR ≤ 0.5, intraocular difference of CDR < 0.3).
Normal subjects (i) General inclusion criteria: Physical, intellectual and linguistic abilities needed to understand the test requirements: no mobility limimtaions / hemiparesis, Minimental Status Examination Test score above 24, adequate knowledge of the German language, willingness to comply with the protocol, > 18 years, informed consent.
Ophthalmological inclusion criteria: maximum allowed spherical ametropia at distance is ± 6.00 diopters and the maximum cylindrical ametropia is ± 2 diopters. The best corrected distance visual acuities are equal to, or better than 20/20 and 1.0, respectively, for those aged up to 60 years; better than 20/25 and 0.8 for those aged between 60 and 70 years; and better than, or equal to, 20/33 and 0.6 for those aged more than 70 years. All participants manifest equal pupil size, pupil diameter > 3 mm, no relative afferent pupillary defect, intraocular pressure ≤ 21 mmHg, normal anterior segments, no clinically relevant media opacities, normal appearance of the optic disc (cup to disc ratio = CDR ≤ 0.5, intraocular difference of CDR < 0.3) and normal central and peripheral fundus findings on direct and indirect undilated ophthalmoscopic examination.

Who cannot join

Patients with homonymous visual field defects: (i) General exclusion criteria: Pregnancy, nursing, asthma, HIV+ or AIDS, history of epilepsy or significant psychiatric disease, history of drug and alcohol abuse, Minimental Status Examination Test score below 24, medications known to affect visual field sensitivity.
Ophthalmological exclusion criteria: diabetic retinopathy, infections (e.g. keratitis, conjunctivitis, uveitis), severe dry eyes, miotic drug, amblyopia, squint, nystagmus, albinism, any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings, keratoconus, intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening, protanopia, deuteranopia, history or presence of macular disease and / or macular edema, ocular trauma.
Normal subjects: (i) General exclusion criteria: pregnancy, nursing, mental or neurological diseases, Minimental Status Examination Test score below 24, history of coronary heart disease, stroke, diabetes mellitus, migraine, vasospasm/ Raynaud's disease, drugs indicating severe systemic diseases (e.g. anti-diabetic or anti-hypertensive medication for subjects under 70 years of age), drugs or medications influencing reaction time, history of drug and alcohol abuse, suspected lack of compliance. Subjects over 70 years of age will not be excluded for use of anti-hypertensive medication.
Ophthalmological exclusion criteria: Amblyopia, strabismus, ocular motility disorders, retinal pathology, glaucoma, suspicion of glaucoma, ocular hypertension or any other sign of other optic neuropathy, macular degeneration, protanopia, deuteranopia, eye surgery (except for uncomplicated cataract surgery), any type of refractive surgery, history or signs of neuro-ophthalmological diseases, acute infections, diabetic retinopathy, use of miotic drugs.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Centre for Ophthalmology Institute for Ophthalmic Research University of Tübingen
Tübingen, Baden-Wurttemberg, D-72076

Other trials in Germany

About this study

The purpose of this explorative study, targeting subjects with homonymous visual field loss, is threefold:

(i) to identify the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score, using a validated questionnaire (NEI-VFQ 25) (ii) to determine, whether gaze-related (exploratory eye movements) or visual field-related (eyes steadily fixating) parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL), as represented by (iia) a standardized visual search task ("supermarket special offer search task") (iib) by an on-road car driving pilot study.

Conditions: Homonymous Hemianopia
Keywords: homonymous hemianopia, quality of life (QoL), visual exploration, on-road car driving, driving simulator, useful field of view (UFOV), modified field of view (MAFOV)
Medical subject headings: Hemianopsia

What participants receive

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

Study groups in NCT01372332
Study group	Role	What they receive
Normal subjects		Age-related (+ 5 years of age) and gender-matched normal subjects.
Patients with homonymous hemianopia		Patients with homonymous visual field defects

What is being measured

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

Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score
Quality of life (QoL) is better correlated with the modified ESTERMAN score of the binocular semi-automated kinetic perimetry of the 90° visual field than with the number of affected test locations (local sensitivity < 10 dB) according to the binocular integrated visual field (IVF)
Measured: 2 years

Secondary outcomes (1)

Exploration whether gaze-related or visual field-related parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL)
1. Activities of daily living ("supermarket special offer search task"), are better correlated with the modified ESTERMAN score, based on the intact binocular gaze field than with the modified ESTERMAN score, based on the binocular semi-automated kinetic perimetry of the 90° visual field (90° SKP)
2. Activities of daily living (driving performance) are better correlated with (the ESTERMAN score, based on) the intact binocular gaze field than with the UFOV risk score
Measured: 2 years

Timeline

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

Jun 2011Apr 2013

First posted13 Jun 2011 (estimated)
Study startJun 2011
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Homonymous HemianopiaStudies of the same condition, open and under way.
More trials run by University Hospital TuebingenThe sponsor's other registered studies.
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: Case-control
Time perspective: Prospective
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01372332
Sponsor's protocol ID: 086/2011BO2
Acronym: Hemi-Drive
Status last verified: May 2014
First submitted: 10 Jun 2011
Last updated: 28 May 2014
Results posted: No
Data monitoring committee: No

Publications

Kasneci E, Sippel K, Aehling K, Heister M, Rosenstiel W, Schiefer U, Papageorgiou E. Driving with binocular visual field loss? A study on a supervised on-road parcours with simultaneous eye and head tracking. PLoS One. 2014 Feb 11;9(2):e87470. doi: 10.1371/journal.pone.0087470. eCollection 2014.
PubMed 24523869
Kübler T, Kasneci E, Rosenstiel W, Schiefer U, Nagel K, Papageorgiou E. Stress-indicators and exploratory gaze for the analysis of hazard perception in patients with visual field loss. Science Direct, Transportation Research Part F 24: 231-43, 2014
Kasneci E, Sippel K, Heister M, Aehling K, Rosenstiel W, Schiefer U, Papageorgiou E. Homonymous Visual Field Loss and Its Impact on Visual Exploration: A Supermarket Study. Transl Vis Sci Technol. 2014 Nov 3;3(6):2. doi: 10.1167/tvst.3.6.2. eCollection 2014 Oct.
PubMed 25374771
Sippel K, Kasneci E, Aehling K, Heister M, Rosenstiel W, Schiefer U, Papageorgiou E. Binocular glaucomatous visual field loss and its impact on visual exploration--a supermarket study. PLoS One. 2014 Aug 27;9(8):e106089. doi: 10.1371/journal.pone.0106089. eCollection 2014.
PubMed 25162522

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

Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Not yet recruiting
Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
Hemianopia Homonymous, Stroke

All Homonymous Hemianopia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Homonymous Visual Loss and Its Impact on Visual Exploration, Activities of Daily Living (ADL) and Quality of Life (QoL)
ClinicalTrials.gov ID: NCT01372332
Acronym / sponsor ID: Hemi-Drive / 086/2011BO2
Conditions: Homonymous Hemianopia
Keywords: homonymous hemianopia, quality of life (QoL), visual exploration, on-road car driving, driving simulator, useful field of view (UFOV), modified field of view (MAFOV)
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Hospital TuebingenUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Jun 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 13 Jun 2011 (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 explorative study, targeting subjects with homonymous visual field loss, is threefold:

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Normal subjects	–	–Age-related (+ 5 years of age) and gender-matched normal subjects.
Patients with homonymous hemianopia	–	–Patients with homonymous visual field defects

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: 30 patients with homonymous visual field defects and 30 age-related (+ 5 years of age) and gender-matched normal subjects. All subjects are free to stop participation of the tests at any time without any consequences on the future treatment of the patient. The circumstances of any discontinuation will be documented.

Key inclusion criteria (5 listed)

Patients with homonymous visual field defects Primary inclusion criterion: (Stable) homonymous visual field defects, as obtained by binocular semi-automated kinetic perimetry (SKP), using the III4e stimulus, within on onset of at least six months ago, due to a vascular or a traumatic lesion.
Further inclusion criteria: (i) general: physical, intellectual and linguistic abilities, necessary to understand the test requirements: no mobility limitations / hemiparesis, Minimental Status Examination Test score above 24, adequate knowledge of the German language, willingness to comply with the protocol, > 18 years, informed consent.
Ophthalmological: spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt, best corrected distant visual acuity > 6/12 (= 0.5), isocoria, pupil diameter > 3 mm, intraocular pressure ≤ 21 mmHg, normal anterior segments, no clinically relevant media opacities, normal appearance of the optic disc (cup to disc ratio = CDR ≤ 0.5, intraocular difference of CDR < 0.3).
Normal subjects (i) General inclusion criteria: Physical, intellectual and linguistic abilities needed to understand the test requirements: no mobility limimtaions / hemiparesis, Minimental Status Examination Test score above 24, adequate knowledge of the German language, willingness to comply with the protocol, > 18 years, informed consent.
Ophthalmological inclusion criteria: maximum allowed spherical ametropia at distance is ± 6.00 diopters and the maximum cylindrical ametropia is ± 2 diopters. The best corrected distance visual acuities are equal to, or better than 20/20 and 1.0, respectively, for those aged up to 60 years; better than 20/25 and 0.8 for those aged between 60 and 70 years; and better than, or equal to, 20/33 and 0.6 for those aged more than 70 years. All participants manifest equal pupil size, pupil diameter > 3 mm, no relative afferent pupillary defect, intraocular pressure ≤ 21 mmHg, normal anterior segments, no clinically relevant media opacities, normal appearance of the optic disc (cup to disc ratio = CDR ≤ 0.5, intraocular difference of CDR < 0.3) and normal central and peripheral fundus findings on direct and indirect undilated ophthalmoscopic examination.

Key exclusion criteria (4 listed)

Patients with homonymous visual field defects: (i) General exclusion criteria: Pregnancy, nursing, asthma, HIV+ or AIDS, history of epilepsy or significant psychiatric disease, history of drug and alcohol abuse, Minimental Status Examination Test score below 24, medications known to affect visual field sensitivity.
Ophthalmological exclusion criteria: diabetic retinopathy, infections (e.g. keratitis, conjunctivitis, uveitis), severe dry eyes, miotic drug, amblyopia, squint, nystagmus, albinism, any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields, disc imaging or accurate IOP readings, keratoconus, intraocular surgery (except for uncomplicated cataract surgery) performed < 3 month prior to screening, protanopia, deuteranopia, history or presence of macular disease and / or macular edema, ocular trauma.
Normal subjects: (i) General exclusion criteria: pregnancy, nursing, mental or neurological diseases, Minimental Status Examination Test score below 24, history of coronary heart disease, stroke, diabetes mellitus, migraine, vasospasm/ Raynaud's disease, drugs indicating severe systemic diseases (e.g. anti-diabetic or anti-hypertensive medication for subjects under 70 years of age), drugs or medications influencing reaction time, history of drug and alcohol abuse, suspected lack of compliance. Subjects over 70 years of age will not be excluded for use of anti-hypertensive medication.
Ophthalmological exclusion criteria: Amblyopia, strabismus, ocular motility disorders, retinal pathology, glaucoma, suspicion of glaucoma, ocular hypertension or any other sign of other optic neuropathy, macular degeneration, protanopia, deuteranopia, eye surgery (except for uncomplicated cataract surgery), any type of refractive surgery, history or signs of neuro-ophthalmological diseases, acute infections, diabetic retinopathy, use of miotic drugs.

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

Primary outcome

Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score
Time frame: 2 years
Quality of life (QoL) is better correlated with the modified ESTERMAN score of the binocular semi-automated kinetic perimetry of the 90° visual field than with the number of affected test locations (local sensitivity < 10 dB) according to the binocular integrated visual field (IVF)

1 secondary outcome

Exploration whether gaze-related or visual field-related parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL)
Time frame: 2 years

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 28 May 2014.
Background: PubMed 24523869Kasneci E, Sippel K, Aehling K, Heister M, Rosenstiel W, Schiefer U, Papageorgiou E. Driving with binocular visual field loss? A study on a supervised on-road parcours with simultaneous eye and head tracking. PLoS One. 2014 Feb 11;9(2):e87470. doi: 10.1371/journal.pone.0087470. eCollection 2014.
BackgroundKübler T, Kasneci E, Rosenstiel W, Schiefer U, Nagel K, Papageorgiou E. Stress-indicators and exploratory gaze for the analysis of hazard perception in patients with visual field loss. Science Direct, Transportation Research Part F 24: 231-43, 2014
Derived from this study: PubMed 25374771Kasneci E, Sippel K, Heister M, Aehling K, Rosenstiel W, Schiefer U, Papageorgiou E. Homonymous Visual Field Loss and Its Impact on Visual Exploration: A Supermarket Study. Transl Vis Sci Technol. 2014 Nov 3;3(6):2. doi: 10.1167/tvst.3.6.2. eCollection 2014 Oct.
Derived from this study: PubMed 25162522Sippel K, Kasneci E, Aehling K, Heister M, Rosenstiel W, Schiefer U, Papageorgiou E. Binocular glaucomatous visual field loss and its impact on visual exploration--a supermarket study. PLoS One. 2014 Aug 27;9(8):e106089. doi: 10.1371/journal.pone.0106089. eCollection 2014.

Related trials for Homonymous Hemianopia

Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Active, not recruiting
Statistical Learning as a Novel Intervention for Cortical Blindness
Stroke, Ischemic, Hemianopia, Homonymous
Not yet recruitingObservational study
Anatomical and Functional Predictions of Blindsight Capabilities in Patients With Lateral Hemianopsia
Homonymous Hemianopia, Stroke
Not yet recruiting
Effects of Optokinetic Stimulation Without a Reading Task in Patients With Hemianopic Alexia
Hemianopia Homonymous, Stroke

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

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 Homonymous Hemianopia, 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 5 inclusion and 4 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 28 May 2014. 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?

Identification of the perimetric / psychophysical method, that is most closely correlated with an individually assessed quality of life (QoL) score (time frame: 2 years). 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 NCT01372332, which also lists 4 linked publications.

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 28 May 2014.