GlaucomaGlaucomaEXPLORNCT01372319
Assessment of Advanced Glaucomatous Visual Field Loss and Its Impact on Visual Exploration, Activities of Daily Living (ADL) and Quality of Life (QoL)
An observational study of Glaucoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this explorative study, targeting subjects with advanced binocular glaucomatous visual field loss, is: (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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- Type of treatment
- Injection or infusion
- 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: First year: 10 glaucoma patients, with advanced binocular visual loss and 10 age-related (+ 5 years of age) and gender-matched normal subjects. Second year: Extension to a total number 30 glaucoma patients, with advanced binocular visual loss and 30 age-related (+ 5 years of age) and gender-matched normal subjects (according to the sample size estimation), if additional budget available.
Who may be able to join
- Glaucoma subjects Primary inclusion criteria: Open angle glaucoma (OAG), according to the classification of the European Glaucoma Society (EGS)11 with advanced binocular visual loss (i.e stages II - IV according to the classification after Aulhorn et al.4, as obtained by semi-automated kinetic perimetry (SKP) or automated static threshold-related, slightly supraliminal perimetry (sAS) 3,10 22 [Grid 30°-NO (192 test points), stimulus Goldmann size III = 26´, OCTOPUS 101/900 perimeter (Haag-Streit Inc., Köniz, Switzerland)].
- Further inclusion criteria: (i) General: physical, intellectual and linguistic abilities, necessary to understand the test requirements: no mobility limitations, 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, distant visual acuity > 10/20, isocoria, pupil diameter > 3 mm.
- Normal subjects (i) General inclusion criteria: Physical, intellectual and linguistic abilities needed to understand the test requirements: no mobility limitations, 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 dpt. The best corrected distance visual acuities are ≥ 20/20 (1.0) for those aged up to 60 years; > 20/25 (0.8) for those aged between 60 and 70 years; ≥ 20/33 (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
- Glaucoma subjects (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, history or signs of any visual pathway affection other than glaucoma, allergies with regard to topic glaucoma medication, history or presence of macular disease and / or macular edema, ocular trauma.
- Normal subjects
- General exclusion criteria: mental or neurological diseases, diabetes mellitus, history of coronary heart disease, stroke, 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, pregnancy, nursing; history of drug and alcohol abuse. 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, pathological color vision test results (Ishihara Standard Pseudoisochromatic Plates), eye surgery (except 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 University of Tübingen
Tübingen, Baden-Wurttemberg, D-72076
About this study
The purpose of this explorative study, targeting subjects with advanced binocular glaucomatous visual field loss, is: (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) OR attention-related parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL), as represented (iia) by a standardized visual search task and (iib) by an on-road car driving feasibility study.
Further this study is intended to introduce and analyse a novel diagnostic method for recording and evaluating exploratory eye movements (gaze-related perimetry) in a clinical setting. A similar procedure has recently been introduced by Murray et al. However, their set-up is based on a video monitor and, therefore, restricted to the central visual field (eccentricity < 25°) and limited with regard to the dynamic range of the stimulus luminance. Since our new gaze-related perimetry is designed to be implemented in a conventional cupola perimeter, it should be widely available as a potent diagnostic tool, for screening purposes, or for clinical surveys by general ophthalmologists or clinical research groups.
- Conditions
- Glaucoma
- Keywords
- glaucoma, binocular visual field loss, semi-automated kinetic perimetry (SKP), quality of life (QoL), visual exploration, on-road car driving, driving simulator
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Patients (OAG, Aulhorn stages II - IV) | Manifest glaucoma (OAG, Aulhorn stages II - IV) with advanced binocular visual loss, as obtained by semi-automated kinetic perimetry (SKP), no study medication | |
| Normal subjects | male+female > 18 years |
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), assessed with the NEI-VFQ 25 questionnaire, is better correlated with the modified ESTERMAN score, based on the binocular semi-automated kinetic perimetry of the 90° visual field (90° SKP) than with the number of affected test locations (local sensitivity < 10 dB) according to the binocular integrated visual field (IVF).
Measured: 2 years
Determination of the most appropriate parameters (gaze-related ; visual field-related; attention-related) for the characterization of the visual capacities for activities of daily living
Performance regarding activities of daily living (ADL), as represented by the "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) OR the with the number of affected test locations (local sensitivity < 10 dB) of the binocular integrated visual field (IVF) OR the UFOV risk score.
Measured: 2 years
Secondary outcomes (3)
Comparison of the comprehensive psychophysical examinations
The scotoma extent, assessed with MAFOV, is equal to the scotoma extent assessed with the fast thresholding conventional static automated perimetry (SAP) (GATE strategy, Grid 30-S). Additionally, test/re-test reliability will be assessed with regard to (i) MAFOV and (ii) SAP (as described above), assuming that test/retest reliability is identical between MAFOV and SAP.
Measured: 2 years
Comparison and evaluation of two different assessments of visual exploration under real-life scenarios ("supermarket special offer search task", "on-road car driving" by means of a dual brake vehicle (optional: driving simulator)
Performance regarding acitivities of daily living (ADL), as assessed by the "supermarket special offer search task" and the "on-road car driving pilot study", are better correlated with (the ESTERMAN score, based on) the intact binocular gaze field than with (the ESTERMAN score, based on) the binocular semi-automated kinetic perimetry of the 90° visual field (90° SKP) OR the with the number of affected test locations (local sensitivity < 10 dB) of the binocular integrated visual field (IVF) OR the UFOV risk score.
Measured: 2 years
Descriptive assessment of structure-function relationships by comparing the results of the different perimetric tests with the morphometric results of HRT III
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- 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 GlaucomaStudies 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)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372319
- Sponsor's protocol ID
- 085/2011B02
- Acronym
- GlaucomaEXPLOR
- 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 24523869Kübler 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 25374771Sippel 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
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 Advanced Glaucomatous Visual Field Loss and Its Impact on Visual Exploration, Activities of Daily Living (ADL) and Quality of Life (QoL)
- ClinicalTrials.gov ID
- NCT01372319
- Acronym / sponsor ID
- GlaucomaEXPLOR / 085/2011B02
- Conditions
- Glaucoma
- Keywords
- glaucoma, binocular visual field loss, semi-automated kinetic perimetry (SKP), quality of life (QoL), visual exploration, on-road car driving, driving simulator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (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 advanced binocular glaucomatous visual field loss, is: (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) OR attention-related parameters are better for the characterization of the visual capacities that are necessary for activities of daily living (ADL), as represented (iia) by a standardized visual search task and (iib) by an on-road car driving feasibility study.
Further this study is intended to introduce and analyse a novel diagnostic method for recording and evaluating exploratory eye movements (gaze-related perimetry) in a clinical setting. A similar procedure has recently been introduced by Murray et al. However, their set-up is based on a video monitor and, therefore, restricted to the central visual field (eccentricity < 25°) and limited with regard to the dynamic range of the stimulus luminance. Since our new gaze-related perimetry is designed to be implemented in a conventional cupola perimeter, it should be widely available as a potent diagnostic tool, for screening purposes, or for clinical surveys by general ophthalmologists or clinical research groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Patients (OAG, Aulhorn stages II - IV) | – | –Manifest glaucoma (OAG, Aulhorn stages II - IV) with advanced binocular visual loss, as obtained by semi-automated kinetic perimetry (SKP), no study medication |
| Normal subjects | – | –male+female > 18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- First year: 10 glaucoma patients, with advanced binocular visual loss and 10 age-related (+ 5 years of age) and gender-matched normal subjects. Second year: Extension to a total number 30 glaucoma patients, with advanced binocular visual loss and 30 age-related (+ 5 years of age) and gender-matched normal subjects (according to the sample size estimation), if additional budget available.
Key inclusion criteria (5 listed)
- Glaucoma subjects Primary inclusion criteria: Open angle glaucoma (OAG), according to the classification of the European Glaucoma Society (EGS)11 with advanced binocular visual loss (i.e stages II - IV according to the classification after Aulhorn et al.4, as obtained by semi-automated kinetic perimetry (SKP) or automated static threshold-related, slightly supraliminal perimetry (sAS) 3,10 22 [Grid 30°-NO (192 test points), stimulus Goldmann size III = 26´, OCTOPUS 101/900 perimeter (Haag-Streit Inc., Köniz, Switzerland)].
- Further inclusion criteria: (i) General: physical, intellectual and linguistic abilities, necessary to understand the test requirements: no mobility limitations, 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, distant visual acuity > 10/20, isocoria, pupil diameter > 3 mm.
- Normal subjects (i) General inclusion criteria: Physical, intellectual and linguistic abilities needed to understand the test requirements: no mobility limitations, 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 dpt. The best corrected distance visual acuities are ≥ 20/20 (1.0) for those aged up to 60 years; > 20/25 (0.8) for those aged between 60 and 70 years; ≥ 20/33 (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 (5 listed)
- Glaucoma subjects (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, history or signs of any visual pathway affection other than glaucoma, allergies with regard to topic glaucoma medication, history or presence of macular disease and / or macular edema, ocular trauma.
- Normal subjects
- General exclusion criteria: mental or neurological diseases, diabetes mellitus, history of coronary heart disease, stroke, 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, pregnancy, nursing; history of drug and alcohol abuse. 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, pathological color vision test results (Ishihara Standard Pseudoisochromatic Plates), eye surgery (except 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), assessed with the NEI-VFQ 25 questionnaire, is better correlated with the modified ESTERMAN score, based on the binocular semi-automated kinetic perimetry of the 90° visual field (90° SKP) than with the number of affected test locations (local sensitivity < 10 dB) according to the binocular integrated visual field (IVF).
Determination of the most appropriate parameters (gaze-related ; visual field-related; attention-related) for the characterization of the visual capacities for activities of daily living
Time frame: 2 years
Performance regarding activities of daily living (ADL), as represented by the "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) OR the with the number of affected test locations (local sensitivity < 10 dB) of the binocular integrated visual field (IVF) OR the UFOV risk score.
3 secondary outcomes
Comparison of the comprehensive psychophysical examinations
Time frame: 2 years
Comparison and evaluation of two different assessments of visual exploration under real-life scenarios ("supermarket special offer search task", "on-road car driving" by means of a dual brake vehicle (optional: driving simulator)
Time frame: 2 years
Descriptive assessment of structure-function relationships by comparing the results of the different perimetric tests with the morphometric results of HRT III
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.
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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
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, 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 5 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). 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 NCT01372319, 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.