Trial Outcomes & Findings for 70 vs 110 Degree Side-cut Angles in Femtosecond LASIK (NCT NCT03122535)
NCT ID: NCT03122535
Last Updated: 2021-05-28
Results Overview
Vision testing without correction, both eyes using Snellen Eye chart
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
one year
Results posted on
2021-05-28
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
FS-LASIK 70 Degree Side-cut Angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
FS-LASIK 110 Degree Side-cut Angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
115 115
|
115 115
|
|
Overall Study
3 Months
|
92 92
|
92 92
|
|
Overall Study
12 Months
|
42 42
|
42 42
|
|
Overall Study
COMPLETED
|
42 42
|
42 42
|
|
Overall Study
NOT COMPLETED
|
73 73
|
73 73
|
Reasons for withdrawal
| Measure |
FS-LASIK 70 Degree Side-cut Angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
FS-LASIK 110 Degree Side-cut Angle
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
68
|
68
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
70 vs 110 Degree Side-cut Angles in Femtosecond LASIK
Baseline characteristics by cohort
| Measure |
All Participants
n=115 Participants
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
115 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
31.96 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
93 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: one yearPopulation: This is a contralateral eye study of 115 subjects, each with one eye randomized to the two study groups.
Vision testing without correction, both eyes using Snellen Eye chart
Outcome measures
| Measure |
FS-LASIK 70 Degree Side-cut Angle
n=115 Participants
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
FS-LASIK 110 Degree Side-cut Angle
n=115 Participants
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
|---|---|---|
|
Uncorrected Visual Acuity at One Year
|
-0.082 logMAR Visual Acuity
Standard Deviation 0.065
|
-0.094 logMAR Visual Acuity
Standard Deviation 0.072
|
SECONDARY outcome
Timeframe: one yearVision testing with correction, both eyes using Snellen Eye chart
Outcome measures
| Measure |
FS-LASIK 70 Degree Side-cut Angle
n=115 Participants
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
FS-LASIK 110 Degree Side-cut Angle
n=115 Participants
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
|---|---|---|
|
Best Corrected Visual Acuity at Year One
|
-0.109 logMAR Visual Acuity
Standard Deviation 0.066
|
-0.116 logMAR Visual Acuity
Standard Deviation 0.060
|
Adverse Events
FS-LASIK 70 Degree Side-cut Angle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
FS-LASIK 110 Degree Side-cut Angle
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FS-LASIK 70 Degree Side-cut Angle
n=115 participants at risk
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
FS-LASIK 110 Degree Side-cut Angle
n=115 participants at risk
Each patient will be masked as to which angle of cut is used in which eye. Each patient will receive a 70 degree cut in one eye and a 110 degree cut in the fellow eye.
FS-LASIK 70 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
FS-LASIK 110 degree side-cut angle: FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
|
|---|---|---|
|
Surgical and medical procedures
Enhancement Needed
|
1.7%
2/115 • Number of events 2 • 1 year
No risk for mortality from treatment
|
1.7%
2/115 • Number of events 2 • 1 year
No risk for mortality from treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place