N/A
N=176
A Safety and Effectiveness Study of PRK Using the ALLEGRETTO WAVE® EYE-Q Excimer Laser System
Myopia · Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT01699087 ↗Enrolled (actual)
176
Serious AEs
1.8%
Results posted
Apr 2017
Primary outcome: Primary: Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively — 100 percentage of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Photorefractive keratectomy (PRK) (Procedure); ALLEGRETTO WAVE EYE-Q excimer laser system (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes Achieving Uncorrected Visual Acuity (UCVA) of 20/40 or Better at Refractive Stability in Eyes With Best Spectacle-corrected Visual Acuity (BSCVA) of 20/20 or Better Preoperatively |
100 | — |
| PRIMARY Percentage of Eyes Achieving Manifest Refraction Spherical Equivalent (MRSE) Within ± 1.0 D of Zero at Refractive Stability |
99.7 | — |
| PRIMARY Percentage of Eyes Achieving MRSE Within ± 0.5 D of Zero at Refractive Stability |
93.3 | — |
| PRIMARY Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 1.0 D of Zero at Refractive Stability |
99.0 | — |
| PRIMARY Percentage of Eyes Achieving Manifest Refractive Cylinder Within ± 0.5 D of Zero at Refractive Stability |
92.7 | — |
| PRIMARY Percentage of Eyes That Have a Change of ≤ 1.0 D in MRSE and Manifest Refractive Cylinder Between Consecutive Scheduled Visits |
90.9; 95.6; 99.7; 100; 99.7; 100 | — |
| PRIMARY Cumulative Incidence of Ocular Serious Adverse Events by Eye |
2; 1 | — |
| PRIMARY Percentage of Eyes With BSCVA Decrease of ≥ 2 Lines From Baseline at Refractive Stability |
0.0 | — |
| PRIMARY Percentage of Eyes With a BSCVA Worse Than 20/40 (for Eyes With BSCVA of 20/20 or Better Preoperatively) at Refractive Stability |
0.0 | — |
| PRIMARY Percentage of Eyes With > 2.0 D of Induced Manifest Refractive Cylinder Magnitude, as Compared to Baseline, at Refractive Stability |
0.0 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of the ALLEGRETTO WAVE EYE-Q excimer laser system for the reduction of myopia with or without astigmatism in subjects undergoing photorefractive keratectomy (PRK) treatment.
Eligibility Criteria
Inclusion Criteria
- Subjects desiring refractive correction of myopia up to -6.00 Diopter (D) sphere with or without astigmatism 0 to -3.00 D and up to -6.00 D manifest refraction spherical equivalent (MRSE) at the spectacle plane measured by manifest refraction;
- Minimum best spectacle corrected visual acuity (BSCVA) in the treated eye of 20/25;
- Uncorrected visual acuity (UCVA) 20/40 or worse in the treated eye;
- Less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions;
- Stable refraction (within ± 0.5 D), as determined by MRSE for a minimum of 12 months prior to surgery;
- Demonstrated stable refraction for contact lens wearers, as specified in protocol;
- Signed informed consent document;
- Willing and able to comply with schedule for follow-up visits;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Females who are pregnant, lactating, or planning a pregnancy during the time course of the study, or have another condition associated with the fluctuation of hormones that could lead to refractive changes;
- Participation in other clinical trials during this study;
- Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study;
- Dry eye syndrome as determined by the short questionnaire for dry eye syndrome;
- Systemic medications that may confound the outcome of the study or increase the risk to the subject by affecting wound healing or tissue repair, including, but not limited to steroids, antimetabolites, immune response modifying drugs, etc.;
- Nystagmus or any other condition that would prevent a steady gaze during the PRK treatment or other diagnostic tests;
- Ocular condition that may predispose the subject to future complications;
- Previous intraocular or corneal surgery;
- Subjects who desire to have monovision;
- A known sensitivity to medications used for study procedures, including PRK;
- Presence or history of any condition or finding that makes the subject unsuitable as a candidate for PRK or study participation or may confound the outcome of the study, in the opinion of the Investigator;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01699087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.