Cataracts
Conditions
Keywords
Intraocular lens
Brief summary
The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).
Interventions
DEVICEUltraSert Preloaded Delivery System
Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
DEVICEiTec Preloaded Delivery System
Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
DEVICEiSert Preloaded Delivery System
Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
DEVICEMonarch III D Manual IOL Delivery System
Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to comprehend and sign a statement of informed consent; * Willing and able to complete all required postoperative visits; * Cataract; * Planned cataract removal by phacoemulsification; * Calculated lens power from 18.0 through 27.0 D inclusive; * Preoperative astigmatism \<1.0D; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Systemic disease that affects the cornea; * Any inflammation or edema of the cornea; * Previous or planned refractive or corneal surgery during the subject's participation in the study; * Previous corneal transplant; * Previous retinal detachment; * Pregnancy or lactation, current or planned, during the course of the study; * Current participation in another investigational drug or device study that may confound the results of this investigation; * Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) | Day 0, operative day | Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D) | Day 0, operative day | Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 4 study centers located in Spain and 2 study centers located in France.
Pre-assignment details
Of the 114 enrolled, 2 subjects did not meet inclusion/exclusion criteria, and 3 subjects were excluded prior to randomization for other reasons (ie, the maximum number of randomized subjects was reached). This reporting group includes all randomized subjects (109).
Participants by arm
| Arm | Count |
|---|---|
| UltraSert Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery | 19 |
| iTec Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery | 26 |
| iSert Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery | 26 |
| Monarch III D Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery | 28 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 1 |
| Overall Study | Reason not given | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | UltraSert | iTec | iSert | Monarch III D | Total |
|---|---|---|---|---|---|
| Age, Continuous | 71.4 years STANDARD_DEVIATION 8.71 | 70.7 years STANDARD_DEVIATION 8.31 | 73.0 years STANDARD_DEVIATION 7.27 | 72.5 years STANDARD_DEVIATION 7.1 | 71.9 years STANDARD_DEVIATION 7.73 |
| Sex: Female, Male Female | 14 Participants | 13 Participants | 14 Participants | 17 Participants | 58 Participants |
| Sex: Female, Male Male | 5 Participants | 13 Participants | 12 Participants | 11 Participants | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 19 | 0 / 26 | 0 / 26 | 0 / 28 |
| other Total, other adverse events | 0 / 114 | 0 / 19 | 0 / 26 | 0 / 26 | 0 / 28 |
| serious Total, serious adverse events | 1 / 114 | 0 / 19 | 1 / 26 | 0 / 26 | 0 / 28 |
Outcome results
Primary
Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.
Time frame: Day 0, operative day
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UltraSert | Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) | 2.35 mm | Standard Error 0.019 |
| iTec | Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) | 2.47 mm | Standard Error 0.016 |
| iSert | Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert) | 2.54 mm | Standard Error 0.019 |
Secondary
Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.
Time frame: Day 0, operative day
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UltraSert | Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D) | 2.35 mm | Standard Error 0.019 |
| iTec | Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D) | 2.49 mm | Standard Error 0.011 |