Trial Outcomes & Findings for Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Fabry Patients (NCT NCT02023086)
NCT ID: NCT02023086
Last Updated: 2024-09-19
Results Overview
OSOME measurement of the blood oxygenation at the optic nerve head
Recruitment status
COMPLETED
Target enrollment
8 participants
Primary outcome timeframe
2 years
Results posted on
2024-09-19
Participant Flow
Treatment group (Fabry) were actively recruited
Historic control group. Data collected from the files of patients - matched for age and sex- who consulted at Clinique Universitaire de la Vision. No active recruitment due to constraints in budget and manpower.
Participant milestones
| Measure |
FABRY Group
* contrast sensitivity measurement
* slit lamp assessment and intra-ocular pressure measurement
* ocular coherence tomography at the optic nerve head
* visual field testing
* OSOME (oxygen flow at the optic nerve head measurement)
|
CONTROL Group
* contrast sensitivity measurement
* slit lamp assessment and intra-ocular pressure measurement
* ocular coherence tomography at the optic nerve head
* visual field testing
* oxygen flow at the optic nerve head measurement (OSOME)
C
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
FABRY Group
* contrast sensitivity measurement
* slit lamp assessment and intra-ocular pressure measurement
* ocular coherence tomography at the optic nerve head
* visual field testing
* OSOME (oxygen flow at the optic nerve head measurement)
|
CONTROL Group
* contrast sensitivity measurement
* slit lamp assessment and intra-ocular pressure measurement
* ocular coherence tomography at the optic nerve head
* visual field testing
* oxygen flow at the optic nerve head measurement (OSOME)
C
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
Baseline characteristics by cohort
| Measure |
FABRY Group
n=8 Participants
* contrast sensitivity measurement
* slit lamp assessment and intra-ocular pressure measurement
* ocular coherence tomography at the optic nerve head
* visual field testing
* OSOME (oxygen flow at the optic nerve head measurement)
|
CONTROL Group
n=8 Participants
* contrast sensitivity measurement
* slit lamp assessment and intra-ocular pressure measurement
* ocular coherence tomography at the optic nerve head
* visual field testing
* oxygen flow at the optic nerve head measurement (OSOME)
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Hemizygotes- males · <=18 years
|
0 Participants
n=3 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
0 Participants
n=3 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
0 Participants
n=6 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
|
Age, Categorical
Hemizygotes- males · Between 18 and 65 years
|
3 Participants
n=3 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
3 Participants
n=3 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
6 Participants
n=6 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
|
Age, Categorical
Hemizygotes- males · >=65 years
|
0 Participants
n=3 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
0 Participants
n=3 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
0 Participants
n=6 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
|
Age, Categorical
Heterozygotes- females · <=18 years
|
0 Participants
n=5 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
0 Participants
n=5 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
0 Participants
n=10 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
|
Age, Categorical
Heterozygotes- females · Between 18 and 65 years
|
4 Participants
n=5 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
4 Participants
n=5 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
8 Participants
n=10 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
|
Age, Categorical
Heterozygotes- females · >=65 years
|
1 Participants
n=5 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
1 Participants
n=5 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
2 Participants
n=10 Participants • The number analyzed in rows are detailled by category. The total of the participants in the 2 rows = overall number of participants. There is NO error
|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 14.8 • n=8 Participants
|
43 years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
46 years
STANDARD_DEVIATION 14.8 • n=16 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=16 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
16 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Fabry disease patients
OSOME measurement of the blood oxygenation at the optic nerve head
Outcome measures
| Measure |
Fabry
n=8 Participants
Fabry participants
|
CONTROL Group
n=8 Participants
Historical control group Results extract from database
|
|---|---|---|
|
Blood Oxygenation at the Optic Nerve Head
|
60.8 percentage of oxygen saturation
Standard Deviation 5.4
|
65.3 percentage of oxygen saturation
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Fabry patients vs historic database
Visual field defect using Frequency Doubling Technology (FDT) Results from FDT perimetry are reported using decibels of sensitivity. FDT perimetry has a manufacturer-provided internal normative database. (Deviation Plot). Results are compared to the normative database are shown on a gray scale plot based on probability levels. Screening tests preformed with the -5 screening test index ranges from P≥5% (worst) to P\<1% (better) The global indices that are reported are the mean deviation (MD) and pattern standard deviation (PSD). MD values that fall below 5%, 2% 1% or 0.5 % normal probability levels are indicated with the appropriate label. Pattern Standard Deviation (PSD) represents how evenly the field loss is spread across the VF, thus indicative of localized loss. The PSD can only be equal to or greater than zero. The higher the PSD value, the greater the amount of irregularities with steeper slopes in the VF.
Outcome measures
| Measure |
Fabry
n=8 Participants
Fabry participants
|
CONTROL Group
n=8 Participants
Historical control group Results extract from database
|
|---|---|---|
|
Field Defect
|
98.4 Visual field Index (VFI)
Standard Deviation 1.1
|
99.6 Visual field Index (VFI)
Standard Deviation 0.6
|
Adverse Events
FABRY Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place