Cataract
Conditions
Keywords
cataract, intraocular lens, IOL, blue light filter
Brief summary
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.
Interventions
DEVICEClear clip-on glasses
Clip-on glasses with no light filtering properties
Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months; * Good ocular health; * 20/40 or better vision with best correction in both eyes; * Willing to provide voluntary consent and sign informed consent form; * Able to competently perform testing; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photostress Recovery Time | Day 1 | 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. |
Participant flow
Recruitment details
Participants were recruited from 6 study sites located in the US.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Overall Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment. | 156 |
| Total | 156 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 69.9 years STANDARD_DEVIATION 8.04 |
| Sex: Female, Male Female | 91 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 158 | 0 / 158 |
| serious Total, serious adverse events | 0 / 158 | 0 / 158 |
Outcome results
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.
Time frame: Day 1
Population: This analysis population includes all participants with observation minus any major protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blue Light Filter | Photostress Recovery Time | 5.66 seconds | Standard Deviation 6.2 |
| Clear | Photostress Recovery Time | 6.94 seconds | Standard Deviation 7.16 |