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

• Sponsor: Clinical Research Consultants, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01028378
• Collaborator: Alcon Research (Industry), WaveLight AG (Industry)
• Enrollment: 212
• Locations: 10
• Arm: 1
• Patients Per Site: 21.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia; Hyperopia	Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 212 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topography-guided LASIK Topography-guided LASIK for Myopia or Hyperopia	Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser

Outcome Measures

Primary Outcome Measures

1. Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D [12 month]

2. Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D [12 month]

3. Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D [12 month]

4. Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better [12 month]

5. Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively [12 month]

6. Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA) [12 month]

7. Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40 [12 month]

8. Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only) [12 month]

9. Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively [12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milauskas Eye Institute	La Quinta	California	United States	92253
2	Gordon & Weiss Vision Institute	San Diego	California	United States	92122
3	Woolfson Eye Institute	Atlanta	Georgia	United States	30328
4	Emory Vision	Atlanta	Georgia	United States	30342
5	Bond Eye Associates	Peoria	Illinois	United States	61614
6	Durrie Vision	Overland Park	Kansas	United States	66211
7	TLC Laser Eye Center	Greensboro	North Carolina	United States	27410
8	Memorial Eye Institute	Harrisburg	Pennsylvania	United States	17112
9	Laser Vision of Texas	Houston	Texas	United States	77027
10	International Eye Care Laser Center	Houston	Texas	United States	77079

Sponsors and Collaborators

• Clinical Research Consultants, Inc.
• Alcon Research
• WaveLight AG

Investigators

• Study Director: Doyle Stulting, M.D., Ph.D., Woolfson Eye Institute/Medical Monitor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinical Research Consultants, Inc.
• ClinicalTrials.gov Identifier: NCT01028378
• Other Study ID Numbers: T-CAT-001
• First Posted: Dec 9, 2009
• Last Update Posted: Apr 11, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Myopia; Hyperopia

Study Results

Participant Flow

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Period Title: Overall Study
STARTED	212
COMPLETED	195
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Overall Participants	212
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34 (9.3)
Sex: Female, Male (Count of Participants)
Female	93 43.9%
Male	119 56.1%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	157 74.1%
Black	4 1.9%
Asian	8 3.8%
Hispanic	37 17.5%
Other	6 2.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	94.78

2. Primary Outcome

Title	Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 1.00 D
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	99.57

3. Primary Outcome

Title	Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 2.00 D
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	100

4. Primary Outcome

Title	Percentage of Eyes With Uncorrected Visual Acuity (UCVA) 20/20 or Better
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	92.61

5. Primary Outcome

Title	Percentage of Eyes With UCVA 20/40 or Better if BSCVA 20/20 or Better Preoperatively
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	99.56

6. Primary Outcome

Title	Percentage of Eyes With Loss of 2 or More Lines Best Spectacle-Corrected Visual Acuity (BSCVA)
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	0.43

7. Primary Outcome

Title	Percentage of Eyes With Best Spectacle-Corrected Visual Acuity (BSCVA) Worse Than 20/40
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	0

8. Primary Outcome

Title	Percentage of Eyes With an Increase > 2D Cylinder (Spherical Only)
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	0

9. Primary Outcome

Title	Percentage of Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) Worse Than 20/40 if 20/20 or Better Preoperatively
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Measure Participants	195
Measure Number of Eyes	230
Number (95% Confidence Interval) [Percentage of Eyes]	0

Adverse Events

Time Frame	12 months
Arm/Group Title	Topography-guided LASIK
Arm/Group Description	Topography-guided LASIK for Myopia or Hyperopia T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
All Cause Mortality
	Topography-guided LASIK
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Topography-guided LASIK
	Affected / at Risk (%)	# Events
Total	0/195 (0%)
Other (Not Including Serious) Adverse Events
	Topography-guided LASIK
	Affected / at Risk (%)	# Events
Total	2/195 (1%)
Eye disorders
BSCVA loss of 2 or more lines	1/195 (0.5%)
Retinal Detachments	1/195 (0.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.