Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00304824
Status:
COMPLETED
Last Update Posted:
2008-09-26
First Post:
2006-03-17
Brief Title:
Assessment of the Ability to Distinguish Odors in Glaucoma Patients
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Olfactory Function in Glaucoma Patients
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Apoptosis of neurons also plays a major role in neurodegenerative diseases such as Alzheimers or Parkinsons 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:
1 Introduction
1 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 Alzheimers or Parkinsons 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
2 Study objectives Primary Objective To test the olfactory function in glaucoma patients
3 Investigational plan Chronic glaucoma patients will be assessed regarding inclusionexclusion 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
4 Design Single center cohort study normative database as control
5 Selection of study population
I 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 hyposmiaanosmia or interfere with the olfactory function such as polyps chronic sinus infection subacute viral or bacterial infection history of sinus surgery will be considered as an exclusion criterion
V Study medication NA
6 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
7 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
2 Methods of evaluation
a Sniffing Sticks test battery7 Commercially available felt-tip pens 14 cm long and with an inner diameter of 13 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 pens 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 patients 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
3 Statistical procedures
1 Biometric methods Mann-Whitney U-test p005 being considered significant
2 Statistical model Olfactory scores of glaucoma patients will be compared to the age-matched normative database by means of Mann-Whitney U-test
3 Study power No power calculations were performed as there are no prior pilot studies
1 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 Alzheimers or Parkinsons 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
2 Study objectives Primary Objective To test the olfactory function in glaucoma patients
3 Investigational plan Chronic glaucoma patients will be assessed regarding inclusionexclusion 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
4 Design Single center cohort study normative database as control
5 Selection of study population
I 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 hyposmiaanosmia or interfere with the olfactory function such as polyps chronic sinus infection subacute viral or bacterial infection history of sinus surgery will be considered as an exclusion criterion
V Study medication NA
6 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
7 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
2 Methods of evaluation
a Sniffing Sticks test battery7 Commercially available felt-tip pens 14 cm long and with an inner diameter of 13 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 pens 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 patients 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
3 Statistical procedures
1 Biometric methods Mann-Whitney U-test p005 being considered significant
2 Statistical model Olfactory scores of glaucoma patients will be compared to the age-matched normative database by means of Mann-Whitney U-test
3 Study power No power calculations were performed as there are no prior pilot studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None