Visual Acuity
Conditions
Keywords
bilateral implantation, ReSTOR Aspheric IOL, uniocular unaided distance, binocular unaided distance, intermediate visual acuity, near visual acuity
Brief summary
The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.
Interventions
DEVICERESTOR IOL Model SA60D3
Implanted into the study eye following cataract extraction surgery
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥21 years of either gender or any race * Potential post-op VA 20/20 * Pre-op astigmatism ≤ 1.0D * Able to sign the informed consent * Able to complete all required postoperative visits * Planned cataract removal by phaco * Clear intraocular media other than cataract
Exclusion criteria
* Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture * Any corneal pathology and previous corneal refractive surgery * Patients with unrealistic expectations in anticipated post-op VA * Happy to wear glasses * Occupational night driver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Near Uncorrected Visual Acuity(UCVA | 6 months after surgery of 2nd eye | Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity. |
Secondary
| Measure | Time frame |
|---|---|
| Contrast Sensitivity | 6 months after sugery of the 2nd eye |
Countries
United States
Participant flow
Recruitment details
Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation
Pre-assignment details
Open-label, single arm and nonrandomized
Participants by arm
| Arm | Count |
|---|---|
| AcrySof ReSTOR IOL Acrysof ReSTOR Intraocular Lens (IOL) | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | AcrySof ReSTOR IOL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Near Uncorrected Visual Acuity(UCVA
Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.
Time frame: 6 months after surgery of 2nd eye
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AcrySof ReSTOR IOL | Near Uncorrected Visual Acuity(UCVA | 0.5 logMAR | Standard Deviation 0.12 |
Secondary
Contrast Sensitivity
Time frame: 6 months after sugery of the 2nd eye