Trial Outcomes & Findings for A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism (NCT NCT04111757)
NCT ID: NCT04111757
Last Updated: 2024-06-14
Results Overview
Predictability is defined as the difference between the attempted and achieved manifest refraction spherical equivalent (MRSE) at the time of refractive stability.
COMPLETED
NA
168 participants
Assessed at Month 3 to Month 9
2024-06-14
Participant Flow
Unit of analysis: Eyes
Participant milestones
| Measure |
Technolas TENEO 317 Model 2
One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0.
Technolas® TENEO 317 Model 2: LASIK eye surgery
|
|---|---|
|
Overall Study
STARTED
|
168 333
|
|
Overall Study
COMPLETED
|
168 316
|
|
Overall Study
NOT COMPLETED
|
0 17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study With Technolas® TENEO 317 Model 2 Excimer Laser to Treat Participants With Myopia or Myopic Astigmatism
Baseline characteristics by cohort
| Measure |
Technolas TENEO 317 Model 2
n=333 Eyes
One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0.
Technolas® TENEO 317 Model 2: LASIK eye surgery
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
168 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.5 Years
STANDARD_DEVIATION 6.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
168 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at Month 3 to Month 9Predictability is defined as the difference between the attempted and achieved manifest refraction spherical equivalent (MRSE) at the time of refractive stability.
Outcome measures
| Measure |
Technolas TENEO 317 Model 2
n=333 Eyes
One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0.
Technolas® TENEO 317 Model 2: LASIK eye surgery
|
|---|---|
|
Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D
±0.50 Diopter
|
287 Eyes
|
|
Percentage of Eyes That Achieve MRSE Predictability Within ±0.50 Diopter (D) and ±1.00 D
±1.00 Diopter
|
302 Eyes
|
PRIMARY outcome
Timeframe: Assessed at Month 3 to Month 9Percentage of eyes targeted for emmetropia that achieve UDVA of 20/40 or better at the point at which refractive stability is reached.
Outcome measures
| Measure |
Technolas TENEO 317 Model 2
n=333 Eyes
One or both eyes of participants will undergo LASIK surgery with the Technolas® TENEO 317 Model 2 (version 1.28 US software) Excimer Laser on Day 0.
Technolas® TENEO 317 Model 2: LASIK eye surgery
|
|---|---|
|
Percentage of Eyes Targeted for Emmetropia That Achieve Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better
|
304 Eyes
|
Adverse Events
Technolas TENEO 317 Model 2
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact Sponsor directly for details
- Publication restrictions are in place
Restriction type: OTHER