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| Name | Class |
|---|---|
| CIBA VISION | INDUSTRY |
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To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.
To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| soft contact lens | Experimental |
| |
| non-lens wear | No Intervention | control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft contact lens | Device | Soft contact lens |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. | baseline |
| Visual Acuity | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. | 9 month |
| Neovascularisation | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. | baseline |
| Neovascularization | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. | 9 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Desmond Fonn | Centre for Contact Lens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, University of Waterloo, | Waterloo | Ontario | N2L 3G1 | Canada |
38 participants recruited and screened; 4 withdrew by subject
Participants recruited from local communities in Kitchener-Waterloo, Canada between July 2006 and Feb 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | soft lens wearers with sign of hypoxia and high prescription |
| FG001 | Control Group | normal non-lens wearers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | soft lens wearers with sign of hypoxia and high prescription |
| BG001 | Control Group | normal non-lens wearers |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. | Per Protocol. Only the data from participants who completed all study visits were analyzed. | Posted | Mean | Standard Deviation | logMAR | baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | soft lens wearers with sign of hypoxia and high prescription |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Woods | Centre for Contact Lens Research | 1-519-888-4567 | 36547 | cawoods@uwaterloo.ca |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Visual Acuity | level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision. | Posted | Mean | Standard Deviation | logMAR | 9 month |
|
|
|
| Primary | Neovascularisation | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. | Posted | Mean | Standard Deviation | mm | baseline |
|
|
|
| Primary | Neovascularization | length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration. | Posted | Mean | Standard Deviation | mm | 9 month |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Control Group | normal non-lens wearers | 0 | 12 | 0 | 12 |
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