Comparison of Topography Guided LASIK with WaveLight EX500 to SMILE with Zeiss VisuMax

Not Applicable

Withdrawn

• Conditions: Diseases of the eye and adnexa

• Registration Number: KCT0002308
• Lead Sponsor: Sungmo Eye Hospital of Sekwang Medical Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Below is a list of inclusion criteria. Ocular criteria must be met in both eyes.

1. Subjects upon completion of 19 years of age or older.

2. Able to comprehend and sign an Informed Consent Form.

3. Willing and able to complete all post-surgery visits.

4. Myopia requiring (a) refractive error correction of -0.5 to -8.0 D manifest refraction sphere with
(b) astigmatism correction of -0.75 to -5.0 D manifest refraction cylinder and
(c) at least 0.75 D of corneal astigmatism.

5. Intended treatment is targeted for emmetropia.

6. Pre-surgery Best-corrected visual acuity of 0 logarithm of the minimum angle of resolution (logMAR) (20/20) or better.

7. Spherical equivalent difference of = 0.5 D between the manifest and cycloplegic refraction outcomes.

8. Spherical equivalent difference of = 0.5 D between refractive error corrections for a minimum of 12 months prior to surgery verified by consecutive refractions and/or medical records or prescription history.

9. For contact lens wearers - Spherical equivalent difference of = 0.5 D between outcomes from consecutive manifest refraction outcomes performed at least 7 days apart after the contact lens wear has been stopped for the appropriate period of time as follows:

•Soft (extended and daily wear) = 3 days
•Rigid Gas Permeable (RGP) or Toric = 2 weeks
•Hard polymethyl methacrylate (PMMA) = 3 weeks

Exclusion Criteria

Below is a list of exclusion criteria. Ocular criteria must not be met in either eye.

1. Pregnancy or lactation, current or planned, during the course of the study.

2. Manifest refraction astigmatism that is more than 1.00 D than the topolyzer astigmatism assessed by Topolyzer Vario.

3. Mixed astigmatism refractive error.

4. Degenerations of structure of the cornea including diagnosed keratoconus, forme fruste kerataconus or pellucid marginal degeneration.

5. Dry eye as identified by the Short questionnaire for dry eye syndrome.

6. A calculated residual stromal bed thickness that is less than 250 µm.

7. History or evidence of active or inactive corneal or other anterior segment disease (e.g, herpes simplex keratitis, recurrent erosion syndrome).

8. Diagnosed advanced glaucoma.

9. Uncontrolled diabetes.

10. Nystagmus or any other condition that would prevent a steady gaze during the treatment.

11. Previous intraocular or corneal surgery.

12. Weakened immune system, including diagnosed collagen vascular, autoimmune or immunodeficiency disease.

13. Systemic medications that may affect corneal healing including, but not limited to steroids, antimetabolites, immune response modifying drugs, etc.

14. Presence or history of any condition or finding that makes the subject unsuitable as a candidate for refractive surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.

15. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.

16. A known sensitivity to medications used during the study.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of eyes with manifest refraction cylinder = 0.5 D

Secondary Outcome Measures

Name	Time	Method
Mean manifest refraction cylinder;Mean Uncorrected visual acuity;Frequency of Adverse events;Mean intraocular pressure (IOP);Frequency of slip lamp findings;Frequency of dilated fundus examination;Frequency of device deficiencies;Mean Best-corrected visual acuity / Percentage of eyes with post-surgery Best-corrected visual acuity two lines better, one line better, one line worse, two lines worse than pre-surgery Best-corrected visual acuity;Mean mesopic uncorrected contrast sensitivity at each contrast level;Refractive status and vision profile (Mean overall and subscale vision related quality of life score), Short questionnaire for dry eye syndrome (Frequency of dry eye syndrome)