Phase 1
N=357
Use of the VisuMax™ Femtosecond Laser
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01638390 ↗Enrolled (actual)
357
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Effectiveness- Predictability of Participant Refractive Outcomes — 291; 306 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Treatment with the VisuMax™ Femtosecond Laser (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Carl Zeiss Meditec, Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness- Predictability of Participant Refractive Outcomes |
291; 306 | — |
| PRIMARY Effectiveness- Number of Participants With an Improvement in UCVA Following Treatment |
309 | — |
| PRIMARY Stability Criteria- Number of Participants With a Change Between Visits Within 1.00 Diopter (D) |
327 | — |
| PRIMARY Safety- Number of Participants With a Preservation of Best-Spectacle Corrected Visual Acuity (BSCVA) |
0; 0 | — |
| PRIMARY Safety- Number of Participants With Induced Manifest Refractive Astigmatism |
— | — |
| PRIMARY Safety- Number of Participants With Adverse Events |
1; 1; 1; 1; 1; 1 | — |
| PRIMARY Safety- Contrast Sensitivity of Participants |
72; 232; 5 | — |
| PRIMARY Stability Criteria- Number of Participants With a Change Between Visits Within 0.50 Diopter (D) |
317 | — |
| SECONDARY Safety- Participant Symptoms |
116; 71; 122; 93; 95; 121 | — |
Summary
The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE (Manifest Refractive Spherical Equivalent) ≤ -8.25 D.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects age 22 years of age and older;
- Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated;
- A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;
- A difference between cycloplegic and manifest refractions of 8.0 mm;
- Cylinder > -0.50 D;
- Treatment depth is less than 250 microns from the corneal endothelium;
- Eye to be treated is targeted for monovision;
- Fellow eye has BSCVA worse than 20/40;
- Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
- History of or current anterior segment pathology, including cataracts in the eye to be treated;
- Clinically significant dry eye syndrome unresolved by treatment in either eye;
- Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye to be treated;
- Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
- Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
- History of ocular herpes zoster or herpes simplex keratitis;
- Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
- Difficulty following directions or unable to fixate;
- Previous intraocular or corneal surgery of any kind in the eye to be treated, including any type of surgery for either refractive or therapeutic purposes;
- History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye;
- History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
- Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
- History of known sensitivity to planned study medications;
- Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
- Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
Data sourced from ClinicalTrials.gov (NCT01638390). 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.