Cataract
Conditions
Keywords
Cataract, Patients, bilateral, age related, undergoing, phacoemulsification
Brief summary
Randomized contralateral clinical trial with single piece (Model SN60WF) vs. three piece (Model MA60AC) AcrySof Intraocular Lenses (IOLs) on development of Posterior Chamber Opacifiation (PCO).
Interventions
DEVICEModel SN60WF
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
DEVICEModel MA60AC
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 50 years * Clear cornea * Pupil mydriasis ≥ 7mm * In the bag Intraocular Lens (IOL)
Exclusion criteria
* Ocular pathology - uveitis, glaucoma, pseudoexfoliation syndrome (PEX), high myopia * Previously operated eye * Proliferative diabetic retinopathy * Surgical complications - incomplete rhexis, post capsular rupture (PCR), zonular dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posterior Capsule Opacification (PCO) | Up to 3 years | Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Model SN60WF Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | 81 |
| Model MA60AC Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) | 81 |
| Total | 162 |
Baseline characteristics
| Characteristic | Model SN60WF | Model MA60AC | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 23 Participants | 23 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 58 Participants | 116 Participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 41 Participants | 41 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 81 |
| serious Total, serious adverse events | 0 / 81 | 0 / 81 |
Outcome results
Primary
Posterior Capsule Opacification (PCO)
Development of PCO using the EPCO Score. The EPCO score incorporates planimetric & grading assessments. The density of the opacification behind the Intraocular Lens (IOL) is graded clinically as follows: 0=No detectable opacification; 1=Minimal detectable opacification; 2=mild detectable opacification; 3=moderate detectable opacification; 4=severe detectable opacification. The individual PCO score is calculated by multiplying the opacification grade by the fraction of capsule area involved behind the IOL optic. The selection process and grading of areas are subjective.
Time frame: Up to 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Model SN60WF | Posterior Capsule Opacification (PCO) | 0.18 Units on a scale | Standard Deviation 0.41 |
| Model MA60AC | Posterior Capsule Opacification (PCO) | 0.15 Units on a scale | Standard Deviation 0.44 |