Randomized Contralateral Clinical Trial With Single-piece (SN60WF) vs. Three Piece (MA60AC) AcrySof Intraocular Lenses (IOLs) on Development of Posterior Chamber Opacification (PCO).
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Model SN60WF Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) |
Device: Model SN60WF
Implantation with the AcrySof Model SN60WF Single-piece intraocular lens (IOL) following cataract removal.
|
| Active Comparator: Model MA60AC Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
Device: Model MA60AC
Implantation with the AcrySof Model MA60AC multi-piece intraocular lens (IOL) following cataract surgery.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Alcon Call Center for Study Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P-06-03
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Model SN60WF | Model MA60AC |
|---|---|---|
| Arm/Group Description | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
| Period Title: Overall Study | ||
| STARTED | 81 | 81 |
| COMPLETED | 60 | 60 |
| NOT COMPLETED | 21 | 21 |
Baseline Characteristics
| Arm/Group Title | Model SN60WF | Model MA60AC | Total |
|---|---|---|---|
| Arm/Group Description | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) | Total of all reporting groups |
| Overall Participants | 81 | 81 | 162 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
58
71.6%
|
58
71.6%
|
116
71.6%
|
| >=65 years |
23
28.4%
|
23
28.4%
|
46
28.4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
40
49.4%
|
40
49.4%
|
80
49.4%
|
| Male |
41
50.6%
|
41
50.6%
|
82
50.6%
|
Outcome Measures
| Title | Posterior Capsule Opacification (PCO) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Model SN60WF | Model MA60AC |
|---|---|---|
| Arm/Group Description | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) |
| Measure Participants | 60 | 60 |
| Mean (Standard Deviation) [Units on a scale] |
0.18
(0.41)
|
0.15
(0.44)
|
Adverse Events
| Time Frame | Adverse events were not collected for this study. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Model SN60WF | Model MA60AC | ||
| Arm/Group Description | Implantation with the AcrySof Model SN60WF Intraocular Lens (IOL) | Implantation with the AcrySof Model MA60AC Intraocular Lens (IOL) | ||
All Cause Mortality |
||||
| Model SN60WF | Model MA60AC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Model SN60WF | Model MA60AC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/81 (0%) | 0/81 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Model SN60WF | Model MA60AC | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/81 (0%) | 0/81 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
All study data is held confidential and not be disclosed to a 3rd party without written consent from Alcon Laboratories for a period of 3 years.
Results Point of Contact
| Name/Title | Director of Clinical Research |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 888.451.3937; 817.568.6725 |
| medinfo@alconlabs.com |
- P-06-03