Cataract
Conditions
Keywords
ReSTOR Aspheric +3 IOL
Brief summary
A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).
Interventions
DEVICEReSTOR
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with cataracts
Exclusion criteria
* Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens; * \<1 diopter astigmatism by keratometry readings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Visual Acuity (UCVA) | 6 months | Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity. |
Countries
United States
Participant flow
Recruitment details
Subjects 18 - 70 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment details
Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| ReSTOR Aspheric +3 Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes). | 218 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Illness not associated with device | 1 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Unilateral (not bilateral) implantation | 1 |
Baseline characteristics
| Characteristic | ReSTOR Aspheric +3 |
|---|---|
| Age Categorical <=18 years | 0 participants |
| Age Categorical >=65 years | 64 participants |
| Age Categorical Between 18 and 65 years | 143 participants |
| Gender Female | 88 participants |
| Gender Male | 124 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 196 |
| serious Total, serious adverse events | 1 / 196 |
Outcome results
Primary
Uncorrected Visual Acuity (UCVA)
Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. A lower logMAR value indicates better visual acuity.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ReSTOR Aspheric +3 | Uncorrected Visual Acuity (UCVA) | UCVA at 40 cm | 0.05 logMAR | Standard Deviation 0.1 |
| ReSTOR Aspheric +3 | Uncorrected Visual Acuity (UCVA) | UCVA at 50 cm | -0.07 logMAR | Standard Deviation 0.15 |
| ReSTOR Aspheric +3 | Uncorrected Visual Acuity (UCVA) | UCVA at 60 cm | 0.15 logMAR | Standard Deviation 0.14 |
| ReSTOR Aspheric +3 | Uncorrected Visual Acuity (UCVA) | UCVA at 70 cm | 0.20 logMAR | Standard Deviation 0.13 |
| ReSTOR Aspheric +3 | Uncorrected Visual Acuity (UCVA) | UCVA at 4 m | -0.01 logMAR | Standard Deviation 0.11 |