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MyopiaPhase 3NCT01028378

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

A Phase 3 study testing T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser in people with Myopia and Hyperopia, run by Clinical Research Consultants, Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Myopia, Hyperopia
What is being tested?
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
10 sitesUnited States
Study dates
Oct 2009to Apr 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.);
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Woolfson Eye Institute

    Atlanta, Georgia, 30328

  • Emory Vision

    Atlanta, Georgia, 30342

  • TLC Laser Eye Center

    Greensboro, North Carolina, 27410

  • Memorial Eye Institute

    Harrisburg, Pennsylvania, 17112

  • Laser Vision of Texas

    Houston, Texas, 77027

  • International Eye Care Laser Center

    Houston, Texas, 77079

  • Milauskas Eye Institute

    La Quinta, California, 92253

  • Durrie Vision

    Overland Park, Kansas, 66211

  • Bond Eye Associates

    Peoria, Illinois, 61614

  • Gordon & Weiss Vision Institute

    San Diego, California, 92122

Other trials in United States

About this study

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

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.

Conditions
Myopia, Hyperopia
Being tested
T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser
Medical subject headings
Myopia, Hyperopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer LaserDevice

Study groups in NCT01028378
Study groupRoleWhat they receive
Topography-guided LASIKExperimentalTopography-guided LASIK for Myopia or Hyperopia
Receives: Device: T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

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

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01028378
Sponsor's protocol ID
T-CAT-001
Status last verified
Mar 2016
First submitted
7 Dec 2009
Last updated
11 Apr 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser in people with Myopia and Hyperopia, run by Clinical Research Consultants, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) +/- 0.50 D (time frame: 12 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01028378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.

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