Trial Outcomes & Findings for Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia (NCT NCT01028378)

NCT ID: NCT01028378

Last Updated: 2016-04-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 212 participants
• Primary outcome timeframe: 12 month
• Results posted on: 2016-04-11

Participant Flow

Participant milestones

Measure	Topography-guided LASIK Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Overall Study STARTED	212
Overall Study COMPLETED	195
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Topography-guided LASIK Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Overall Study Lost to Follow-up	12
Overall Study Withdrawal by Subject	1
Overall Study Adminstrative Reasons	4

Baseline Characteristics

Safety and Efficacy Study of Topography-Guided LASIK to Treat Myopia and Hyperopia

Baseline characteristics by cohort

Measure	Topography-guided LASIK n=212 Participants Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Age, Continuous	34 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	119 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	157 participants n=5 Participants
Race/Ethnicity, Customized Black	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	8 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	37 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D	94.78 Percentage of Eyes Interval 91.8 to 97.7

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D	99.57 Percentage of Eyes Interval 98.7 to 100.0

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D	100 Percentage of Eyes Interval 100.0 to 100.0

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better	92.61 Percentage of Eyes Interval 89.2 to 96.1

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively	99.56 Percentage of Eyes Interval 98.7 to 100.0

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)	0.43 Percentage of Eyes Interval 0.0 to 1.3

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40	0 Percentage of Eyes Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)	0 Percentage of Eyes Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: 12 month

Outcome measures

Measure	Topography-guided LASIK n=230 Number of Eyes Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively	0 Percentage of Eyes Interval 0.0 to 0.0

Adverse Events

Topography-guided LASIK

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	Topography-guided LASIK n=195 participants at risk Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Eye disorders BSCVA loss of 2 or more lines	0.51% 1/195 • 12 months
Eye disorders Retinal Detachments	0.51% 1/195 • 12 months

Additional Information

Barbara S. Fant, Pharm.D.

Clinical Research Consultants, Inc.

Phone: 513-961-8200

Email: bsfant@crc-regulatory.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place