Trial Outcomes & Findings for Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts (NCT NCT02403206)
NCT ID: NCT02403206
Last Updated: 2018-07-02
Results Overview
A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
406 participants
Primary outcome timeframe
Day 0 (operative day)
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 14 investigative sites: 1 located in Greece, 4 located in India, 2 located in Mexico, 1 located in the Philippines, 3 located in Romania, and 3 located in the US.
Of the 406 enrolled, 6 subjects were exited as screen failures and 10 withdrew prior to randomization. This reporting group includes all randomized subjects (390).
Participant milestones
| Measure |
Laser (LSX)
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
|
Manual (CCC)
Continuous curvilinear capsulorhexis (CCC) performed during cataract surgery
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
196
|
|
Overall Study
Treated Prior to Randomization
|
0
|
1
|
|
Overall Study
Randomized and Treated
|
188
|
190
|
|
Overall Study
COMPLETED
|
183
|
186
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
| Measure |
Laser (LSX)
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
|
Manual (CCC)
Continuous curvilinear capsulorhexis (CCC) performed during cataract surgery
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Reason not given
|
2
|
4
|
Baseline Characteristics
Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts
Baseline characteristics by cohort
| Measure |
Laser (LSX)
n=187 Participants
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
|
Manual (CCC)
n=189 Participants
CCC performed during cataract surgery
|
Total
n=376 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 13.6 • n=93 Participants
|
66.4 years
STANDARD_DEVIATION 11.9 • n=4 Participants
|
65.6 years
STANDARD_DEVIATION 12.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=93 Participants
|
117 Participants
n=4 Participants
|
227 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0 (operative day)Population: Intent-to-Treat Analysis Set
A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Laser (LSX)
n=187 Participants
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
|
Manual (CCC)
n=189 Participants
CCC performed during cataract surgery
|
|---|---|---|
|
Percentage of Capsular Tears (Anterior or Posterior) During Surgery
|
5.3 percentage of capsular tears
|
5.3 percentage of capsular tears
|
SECONDARY outcome
Timeframe: Day 0 (operative day)Population: Intent-to-Treat Analysis Set
Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
Laser (LSX)
n=187 Participants
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
|
Manual (CCC)
n=189 Participants
CCC performed during cataract surgery
|
|---|---|---|
|
Operating Time in the Eye to Complete Entire Cataract Procedure
|
795.0 seconds
Standard Deviation 354.7
|
856.6 seconds
Standard Deviation 436.3
|
Adverse Events
Pretreatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Laser (LSX)
Serious events: 16 serious events
Other events: 46 other events
Deaths: 0 deaths
Manual (CCC)
Serious events: 14 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pretreatment
n=406 participants at risk
All subjects who consented to participate in the study prior to initiation of study treatment
|
Laser (LSX)
n=188 participants at risk
Subjects who underwent femtosecond laser-assisted cataract surgery
|
Manual (CCC)
n=191 participants at risk
Subjects who underwent CCC-assisted cataract surgery
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.53%
1/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Aphakia
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Iridocele
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Iris adhesions
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Iris atrophy
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Posterior capsule rupture
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
2.1%
4/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
1.0%
2/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Vitreous loss
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
1.1%
2/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Injury, poisoning and procedural complications
Cataract operation complication
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.53%
1/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.25%
1/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
4.8%
9/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
4.7%
9/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.53%
1/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Eye operation
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
1.1%
2/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Glaucoma surgery
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.53%
1/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Retinopexy
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.00%
0/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Surgical and medical procedures
Vitrectomy
|
0.25%
1/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
1.6%
3/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
0.52%
1/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
Other adverse events
| Measure |
Pretreatment
n=406 participants at risk
All subjects who consented to participate in the study prior to initiation of study treatment
|
Laser (LSX)
n=188 participants at risk
Subjects who underwent femtosecond laser-assisted cataract surgery
|
Manual (CCC)
n=191 participants at risk
Subjects who underwent CCC-assisted cataract surgery
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
5.9%
11/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
1.0%
2/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Corneal disorder
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
8.5%
16/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
9.9%
19/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
21.3%
40/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
20.4%
39/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/406 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
5.3%
10/188 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
1.6%
3/191 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
|
Additional Information
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