Trial Outcomes & Findings for Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation (NCT NCT02826421)
NCT ID: NCT02826421
Last Updated: 2018-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
Day 0, operative day
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 4 study centers located in Spain and 2 study centers located in France.
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).
Participant milestones
| Measure |
UltraSert
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iTec
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iSert
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
Monarch III D
Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
29
|
28
|
30
|
|
Overall Study
Treated
|
19
|
26
|
26
|
28
|
|
Overall Study
COMPLETED
|
19
|
26
|
26
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
UltraSert
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iTec
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iSert
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
Monarch III D
Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
1
|
1
|
|
Overall Study
Reason not given
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
Baseline characteristics by cohort
| Measure |
UltraSert
n=19 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iTec
n=26 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iSert
n=26 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
Monarch III D
n=28 Participants
Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.4 years
STANDARD_DEVIATION 8.71 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
73.0 years
STANDARD_DEVIATION 7.27 • n=5 Participants
|
72.5 years
STANDARD_DEVIATION 7.10 • n=4 Participants
|
71.9 years
STANDARD_DEVIATION 7.73 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0, operative dayPopulation: Full Analysis Set
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.
Outcome measures
| Measure |
UltraSert
n=19 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iTec
n=26 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iSert
n=26 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
|---|---|---|---|
|
Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
|
2.35 mm
Standard Error 0.019
|
2.47 mm
Standard Error 0.016
|
2.54 mm
Standard Error 0.019
|
SECONDARY outcome
Timeframe: Day 0, operative dayPopulation: Full Analysis Set
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.
Outcome measures
| Measure |
UltraSert
n=19 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iTec
n=28 Participants
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
iSert
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
|
|---|---|---|---|
|
Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
|
2.35 mm
Standard Error 0.019
|
2.49 mm
Standard Error 0.011
|
—
|
Adverse Events
Pretreatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
UltraSert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
iTec
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
iSert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Monarch III D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=114 participants at risk
All subjects who consented to participate in the study prior to initiation of study treatment
|
UltraSert
n=19 participants at risk
All subjects treated with UltraSert
|
iTec
n=26 participants at risk
All subjects treated with iTec
|
iSert
n=26 participants at risk
All subjects treated with iSert
|
Monarch III D
n=28 participants at risk
All subjects treated with Monarch III D
|
|---|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.88%
1/114 • 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.
|
0.00%
0/19 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/28 • 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.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/114 • 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.
|
0.00%
0/19 • 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.
|
3.8%
1/26 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/28 • 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.
|
|
Injury, poisoning and procedural complications
Surgical procedure repeated
|
0.00%
0/114 • 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.
|
0.00%
0/19 • 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.
|
3.8%
1/26 • 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.
|
0.00%
0/26 • 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.
|
0.00%
0/28 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Sr Global Brand Medical Affairs Lead, CDMA Surgical
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER