Cataract
Conditions
Keywords
AcrySof IQ IOL
Brief summary
To determine what effect a blue light filtering Intraocular Lens (IOL) has on macular pigment levels.
Interventions
None listed
Sponsors
Alcon Research
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with existing bilateral IOLs of given type, age-matched patients with normal vision and no cataract surgery.
Exclusion criteria
* Age related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photostress Recovery Time in Seconds. | 3 months | The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. |
Countries
United States
Participant flow
Recruitment details
Patients with existing bilateral intraocular lenses (IOLs) of given type, age-matched patients with normal vision and no cataract surgery.
Pre-assignment details
Subjects eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| AcrySof Natural Intraocular Lens AcrySof Natural Intraocular Lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SN | 17 |
| AcrySof Clear Intraocular Lens AcrySof clear intraocular lens (IOL) - Patients with previous bilateral implant of any Alcon lens model starting with the letters SA | 20 |
| Phakic Patients Phakic patients - Age matched patients who have not had cataract surgery | 21 |
| Total | 58 |
Baseline characteristics
| Characteristic | AcrySof Natural Intraocular Lens | AcrySof Clear Intraocular Lens | Phakic Patients | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 18 Participants | 18 Participants | 51 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 10 Participants | 34 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Photostress Recovery Time in Seconds.
The time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof Natural Intraocular Lens | Photostress Recovery Time in Seconds. | 36 seconds | Standard Deviation 25.94 |
| AcrySof Clear Intraocular Lens | Photostress Recovery Time in Seconds. | 41.46 seconds | Standard Deviation 25.94 |
| Phakic Patients | Photostress Recovery Time in Seconds. | 24.88 seconds | Standard Deviation 15.45 |