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The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clear, then Blue Light Filter | Other | Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction |
|
| Blue Light Filter, then Clear | Other | Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clear clip-on glasses | Device | Clip-on glasses with no light filtering properties |
|
| Measure | Description | Time Frame |
|---|---|---|
| Photostress Recovery Time | Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefani Smith, MS | Alcon Research | Study Director |
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Of the 158 enrolled, 2 participants were exited as screen failures prior to randomization. This reporting group includes all randomized and treated participants (154). Note: 2 participants were randomized but not treated.
Participants were recruited from 6 study sites located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clear, Then Blue Light Filter | Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction |
| FG001 | Blue Light Filter, Then Clear | Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Photostress Recovery Time | Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed. | This analysis population includes all participants with observation minus any major protocol deviations. | Posted | Mean | Standard Deviation | seconds | Day 1 |
|
Adverse events (AEs) were collected for the duration of the study (30 Sep 2013 to 22 Jan 2014). This analysis group includes all enrolled participants.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Reports of AEs were obtained through volunteered and elicited comments from the subjects.
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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 | Blue Light Filter | Blue light filter clip-on glasses worn over habitual correction |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melvin Sarayba, Franchise Head Cataract, GMA | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Blue light filter clip-on glasses | Device | Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 158 |
| 0 |
| 158 |
| EG001 | Clear | Clear clip-on glasses worn over habitual correction | 0 | 158 | 0 | 158 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.