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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UltraSert Preloaded Delivery System | Experimental | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
|
| iTec Preloaded Delivery System | Active Comparator | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
|
| iSert Preloaded Delivery System | Active Comparator | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
|
| Monarch III D Manual IOL Delivery System | Active Comparator | Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UltraSert Preloaded Delivery System | Device | Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, operative day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, GCRA | Alcon Research | Study Director |
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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).
Subjects were recruited from 4 study centers located in Spain and 2 study centers located in France.
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| ID | Title | Description |
|---|---|---|
| FG000 | UltraSert | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| FG001 | iTec | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| FG002 | iSert | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| FG003 | Monarch III D | Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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This analysis population includes all randomized subjects whose cataract surgery procedure was completed (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | UltraSert | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| BG001 | iTec | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set | Posted | Mean | Standard Error | mm | Day 0, operative day |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 31 days). AEs are reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the medical device. Ocular adverse events are presented for both study eye and non-study eye combined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | All subjects who consented to participate in the study prior to initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDRA (19.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Global Brand Medical Affairs Lead, CDMA Surgical | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| iTec Preloaded Delivery System | Device | Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject |
|
| iSert Preloaded Delivery System | Device | 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 |
|
| Monarch III D Manual IOL Delivery System | Device | Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject |
|
| Day 0, operative day |
| Withdrawal by Subject |
|
| Reason not given |
|
| BG002 | iSert | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| BG003 | Monarch III D | Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
| OG002 | iSert | Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery |
|
|
| 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. | Full Analysis Set | Posted | Mean | Standard Error | mm | Day 0, operative day |
|
|
|
| 0 |
| 114 |
| 1 |
| 114 |
| 0 |
| 114 |
| EG001 | UltraSert | All subjects treated with UltraSert | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | iTec | All subjects treated with iTec | 0 | 26 | 1 | 26 | 0 | 26 |
| EG003 | iSert | All subjects treated with iSert | 0 | 26 | 0 | 26 | 0 | 26 |
| EG004 | Monarch III D | All subjects treated with Monarch III D | 0 | 28 | 0 | 28 | 0 | 28 |
| Cataract operation complication | Injury, poisoning and procedural complications | MedDRA (19.0) |
|
| Surgical procedure repeated | Injury, poisoning and procedural complications | MedDRA (19.0) |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.