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

Topography-Guided LASIK Using the ALLEGRETTO WAVE Eye-Q 400 Hz Excimer Laser System For the Treatment of Manifest and Cornea Based Myopic and Hyperopic Optical Errors

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01028378
Enrollment
212
Registered
2009-12-09
Start date
2009-10-31
Completion date
Unknown
Last updated
2016-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperopia, Myopia

Brief summary

This purpose of this study is to evaluate the safety and effectiveness of a topography-based custom ablation treatment using the ALLEGRETTO WAVE® Eye-Q 400 Hz laser system for treating myopia and hyperopia.

Interventions

DEVICET-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser

Sponsors

Alcon Research
CollaboratorINDUSTRY
WaveLight AG
CollaboratorINDUSTRY
Clinical Research Consultants, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age or older; * Signed Informed Consent; * Willingness and ability to comply with schedule for follow-up visits; * be a candidate for topography guided LASIK treatment of myopia or hyperopia in both eyes based on your doctors examination of your eyes; * Intended treatment is targeted for emmetropia; * Stable refraction (0.5 D or less change in manifest refraction spherical equivalent (MRSE) per year) for 12 months or longer, based on previous clinical records or prescription history (e.g., old glasses/contact lens prescriptions). * Able to obtain a reliable corneal topography that can be used to determine the T-CAT treatment plan; * Best spectacle-corrected visual acuity (BSCVA) 20/25 or better in each eye; * Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions. * Is not a contact lens wearer or, if wearing contact lenses, has discontinued wearing contact lenses for the required period of time and completed the contact lens stability check; * be able to maintain your eye position steady during the course of the treatment.

Exclusion criteria

* History of prior refractive treatment; * Mixed astigmatism refractive error; * Lenticular astigmatism that, in the investigator's opinion, is clinically significant; * Corneal topography showing evidence of keratoconus, keratoconus suspect, forme fruste keratoconus, pellucid marginal degeneration, or other topographic abnormality that would place the eye at risk for developing post-refractive corneal ectasia; * Treatment plan for T-CAT would predict a residual stromal bed thickness less than 250 microns; * History or current evidence of corneal or other anterior segment disease that might reasonably be expected to affect the outcome of treatment (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.); * Evidence of retinal vascular disease; * Female patients who are pregnant or lactating or plan to become pregnant during the course of the study; * A known sensitivity to study medications; * Nystagmus or any other condition that would prevent a steady gaze during the LASIK treatment or other diagnostic tests; * Corneal dystrophy or corneal guttae; * Pathology involving the iris (e.g., coloboma, tears, cuts, significant pigment loss, etc.); * Residual, recurrent or active ocular pathology; * Previous intraocular or corneal surgery that might confound the outcome or increase the risk of the study; * Acute or chronic illness that might increase the risk or confound the outcome of the study (e.g., diagnosed autoimmune disease, systemic connective tissue disease, clinically significant atopic disease, diabetes mellitus, etc.) * The use of systemic medications that may confound the outcome or increase the risk of the study, including, but not limited to: corticosteroids and antimetabolites; * Intraocular pressure \> 23 mm Hg, a history of glaucoma, or a glaucoma suspect; * An increased risk for developing strabismus after treatment (applicable only to treatment of hyperopic refractive errors); * Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for LASIK or study participation or may confound the outcome of the study.

Design outcomes

Primary

MeasureTime frame
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D12 month
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D12 month
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D12 month
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better12 month
Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively12 month
Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)12 month
Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/4012 month
Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)12 month
Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively12 month

Countries

United States

Participant flow

Participants by arm

ArmCount
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
212
Total212

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdminstrative Reasons4
Overall StudyLost to Follow-up12
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicTopography-guided LASIK
Age, Continuous34 years
STANDARD_DEVIATION 9.3
Race/Ethnicity, Customized
Asian
8 participants
Race/Ethnicity, Customized
Black
4 participants
Race/Ethnicity, Customized
Caucasian
157 participants
Race/Ethnicity, Customized
Hispanic
37 participants
Race/Ethnicity, Customized
Other
6 participants
Sex: Female, Male
Female
93 Participants
Sex: Female, Male
Male
119 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 195
serious
Total, serious adverse events
0 / 195

Outcome results

Primary

Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With an Increase > 2D Cylinder (Spherical Only)0 Percentage of Eyes
Primary

Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/400 Percentage of Eyes
Primary

Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively0 Percentage of Eyes
Primary

Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)0.43 Percentage of Eyes
Primary

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D94.78 Percentage of Eyes
Primary

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D99.57 Percentage of Eyes
Primary

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D100 Percentage of Eyes
Primary

Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively99.56 Percentage of Eyes
Primary

Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better

Time frame: 12 month

ArmMeasureValue (NUMBER)
Topography-guided LASIKPercentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better92.61 Percentage of Eyes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026