GlaucomaNCT00304824
Assessment of the Ability to Distinguish Odors in Glaucoma Patients
An observational study of Glaucoma, run by University Hospital, Basel, Switzerland.
Trial summary
Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Glaucoma
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Nov 2005
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: glaucoma patients
Who may be able to join
- Chronic open-angle glaucoma with typical glaucomatous disc and visual field damage.
Who cannot join
- Occludable iridocorneal angles
- History of current, chronic or recurrent inflammatory eye disease
- History of retinal or neuroophthalmologic disease that could result in visual field defects
- Need for any concomitant medications that may interfere with the evaluation of olfactory function
- Patients with a significant history and/or active alcohol or drug abuse (significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study), smokers
- History of olfactory disturbance related to identifiable local factors and any local condition that could lead to hyposmia/anosmia or interfere with the olfactory function, such as polyps, chronic sinus infection, sub(acute) viral or bacterial infection, history of sinus surgery
About this study
Official title: Olfactory Function in Glaucoma Patients
Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or Parkinson's disease. An association between glaucoma and these disorders has been described 2-4. Furthermore, it has been reported that the olfactory function is disturbed in these neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in glaucoma which is in fact a local neurodegenerative disease.
Read the detailed description
- Introduction
- Background and rationale of the study Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or Parkinson's disease. An association between glaucoma and these disorders has been described 2-4. Furthermore, it has been reported that the olfactory function is disturbed in these neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in glaucoma which is in fact a local neurodegenerative disease.
- Study objectives Primary Objective: To test the olfactory function in glaucoma patients.
- Investigational plan Chronic glaucoma patients will be assessed regarding inclusion/exclusion criteria and clinical criteria. A basic otorhinolaryngological examination addressing the possible exclusion criteria will be performed prior to the Sniffing Sticks test battery. A simple questionnaire regarding an olfactory status of the patient will be filled out. The olfactory performance of glaucoma patients will be compared to the existing age-matched normative database.
- Design Single center cohort study, normative database as control.
- Selection of study population
- Number of subjects Thirty consecutive glaucoma patients, age 18 - 70, will be recruited from the glaucoma consultation at the University Eye Clinic Basel. II. Prestudy screening A detailed medical and ophthalmic history will be recorded and all patients will complete an ophthalmologic examination (best corrected visual acuity, intraocular pressure measurements, slit-lamp examination, indirect fundoscopy) as well as an otorhinolaryngological examination. III. Inclusion criteria Diagnosis of chronic open-angle glaucoma will be based on the presence of typical glaucomatous disc damage and visual field defects. Only patients with a recent gonioscopic examination and at least two visual field examinations will be recruited. IV. Exclusion criteria Occludable iridocorneal angles, a history of current, chronic or recurrent inflammatory eye disease, a history of retinal or neuroophthalmologic disease that could result in visual field defects, need for any concomitant medications that may interfere with the evaluation of olfactory function, a history of past or active alcohol or drug abuse, smoking, a history of olfactory disturbance related to identifiable local factors, and any local condition that could lead to hyposmia/anosmia or interfere with the olfactory function, such as polyps, chronic sinus infection, sub(acute) viral or bacterial infection, history of sinus surgery, will be considered as an exclusion criterion.
- Study medication NA
- Study protocol I. General restrictions on subjects NA II. Dietary restriction NA. III. Description of study days On the experimental day a detailed history will be taken and a complete ophthalmologic examination including best corrected visual acuity, slit-lamp examination, indirect fundoscopy, and intraocular pressure measurement will be performed (KG). Based on these examinations and chart data, the patient shall be classified as glaucoma patient. A basic otorhinolaryngological screening examination will follow, the patient will fill an olfactory questionnaire and the Sniffing Sticks test battery will be performed (AWL).
- Efficacy variables I. Outcome variables Odor threshold score (0-16), odor discrimination task score (0-16), Odor identification score (0-16), composite score (sum of the three above). II. Follow-up safety investigations NA
- Methods of evaluation
- Sniffing Sticks test battery7 Commercially available felt-tip pens, 14 cm long and with an inner diameter of 1.3 cm, are filled with 4 mL of liquid odorants or odorants dissolved in propylene glycol. For odor presentation the cap is removed by the experimenter for approximately 3 seconds and the pen's tip is placed 2 cm in front of the examined nostril. Three tests are performed. Odor threshold for n-butanol is assessed using a single-staircase, triple-forced choice procedure. Sixteen dilutions are prepared. Three pens are presented at randomized order, with two containing only the solvent. The patient's task is to identify the odor-containing pen. The score ranges from 0 to 16. In the odor-discrimination test, the patient has to determine which of the three presented pens smell differently. A total of 16 triplets is presented to the patient, and thus the score ranges from 0 to 16. Odor identification is assessed by means of 16 common odors, using a multiple choice technique with a list of four descriptors. The score ranges also from 0 to 16. The composite score is the sum of three scores.
- Statistical procedures
- Biometric methods Mann-Whitney U-test, p<0.05 being considered significant.
- Statistical model Olfactory scores of glaucoma patients will be compared to the age-matched normative database by means of Mann-Whitney U-test.
- Study power No power calculations were performed, as there are no prior pilot studies.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Olfactory functions, Sniffing Sticks Test
- Medical subject headings
- Glaucoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startOct 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Selim Orgul, Study director, University Eye Hospital Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304824
- Sponsor's protocol ID
- 009-Guk-2004-002
- Status last verified
- Sep 2008
- First submitted
- 17 Mar 2006
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Function in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT00304824
- Acronym / sponsor ID
- 009-Guk-2004-002
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Olfactory functions, Sniffing Sticks Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 20 Mar 2006 (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.
Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or Parkinson's disease. An association between glaucoma and these disorders has been described 2-4. Furthermore, it has been reported that the olfactory function is disturbed in these neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in glaucoma which is in fact a local neurodegenerative disease.
Detailed description
- Introduction
- Background and rationale of the study Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or Parkinson's disease. An association between glaucoma and these disorders has been described 2-4. Furthermore, it has been reported that the olfactory function is disturbed in these neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in glaucoma which is in fact a local neurodegenerative disease.
- Study objectives Primary Objective: To test the olfactory function in glaucoma patients.
- Investigational plan Chronic glaucoma patients will be assessed regarding inclusion/exclusion criteria and clinical criteria. A basic otorhinolaryngological examination addressing the possible exclusion criteria will be performed prior to the Sniffing Sticks test battery. A simple questionnaire regarding an olfactory status of the patient will be filled out. The olfactory performance of glaucoma patients will be compared to the existing age-matched normative database.
- Design Single center cohort study, normative database as control.
- Selection of study population
- Number of subjects Thirty consecutive glaucoma patients, age 18 - 70, will be recruited from the glaucoma consultation at the University Eye Clinic Basel. II. Prestudy screening A detailed medical and ophthalmic history will be recorded and all patients will complete an ophthalmologic examination (best corrected visual acuity, intraocular pressure measurements, slit-lamp examination, indirect fundoscopy) as well as an otorhinolaryngological examination. III. Inclusion criteria Diagnosis of chronic open-angle glaucoma will be based on the presence of typical glaucomatous disc damage and visual field defects. Only patients with a recent gonioscopic examination and at least two visual field examinations will be recruited. IV. Exclusion criteria Occludable iridocorneal angles, a history of current, chronic or recurrent inflammatory eye disease, a history of retinal or neuroophthalmologic disease that could result in visual field defects, need for any concomitant medications that may interfere with the evaluation of olfactory function, a history of past or active alcohol or drug abuse, smoking, a history of olfactory disturbance related to identifiable local factors, and any local condition that could lead to hyposmia/anosmia or interfere with the olfactory function, such as polyps, chronic sinus infection, sub(acute) viral or bacterial infection, history of sinus surgery, will be considered as an exclusion criterion.
- Study medication NA
- Study protocol I. General restrictions on subjects NA II. Dietary restriction NA. III. Description of study days On the experimental day a detailed history will be taken and a complete ophthalmologic examination including best corrected visual acuity, slit-lamp examination, indirect fundoscopy, and intraocular pressure measurement will be performed (KG). Based on these examinations and chart data, the patient shall be classified as glaucoma patient. A basic otorhinolaryngological screening examination will follow, the patient will fill an olfactory questionnaire and the Sniffing Sticks test battery will be performed (AWL).
- Efficacy variables I. Outcome variables Odor threshold score (0-16), odor discrimination task score (0-16), Odor identification score (0-16), composite score (sum of the three above). II. Follow-up safety investigations NA
- Methods of evaluation
- Sniffing Sticks test battery7 Commercially available felt-tip pens, 14 cm long and with an inner diameter of 1.3 cm, are filled with 4 mL of liquid odorants or odorants dissolved in propylene glycol. For odor presentation the cap is removed by the experimenter for approximately 3 seconds and the pen's tip is placed 2 cm in front of the examined nostril. Three tests are performed. Odor threshold for n-butanol is assessed using a single-staircase, triple-forced choice procedure. Sixteen dilutions are prepared. Three pens are presented at randomized order, with two containing only the solvent. The patient's task is to identify the odor-containing pen. The score ranges from 0 to 16. In the odor-discrimination test, the patient has to determine which of the three presented pens smell differently. A total of 16 triplets is presented to the patient, and thus the score ranges from 0 to 16. Odor identification is assessed by means of 16 common odors, using a multiple choice technique with a list of four descriptors. The score ranges also from 0 to 16. The composite score is the sum of three scores.
- Statistical procedures
- Biometric methods Mann-Whitney U-test, p<0.05 being considered significant.
- Statistical model Olfactory scores of glaucoma patients will be compared to the age-matched normative database by means of Mann-Whitney U-test.
- Study power No power calculations were performed, as there are no prior pilot studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- glaucoma patients
Key inclusion criteria (1 listed)
- Chronic open-angle glaucoma with typical glaucomatous disc and visual field damage.
Key exclusion criteria (6 listed)
- Occludable iridocorneal angles
- History of current, chronic or recurrent inflammatory eye disease
- History of retinal or neuroophthalmologic disease that could result in visual field defects
- Need for any concomitant medications that may interfere with the evaluation of olfactory function
- Patients with a significant history and/or active alcohol or drug abuse (significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study), smokers
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
Not reported in the source record.
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 26 Sep 2008.
- University Basel, SwitzerlandLink provided by the sponsor.
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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.
Selim Orgul study director
University Eye Hospital Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University Hospital, Basel, Switzerland.
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 6 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 26 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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.
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 26 Sep 2008.