Health Condition 1: H527- Unspecified disorder of refraction
Conditions
Interventions
Intervention1: 1. MEL80/MEL90 excimer laser &
2. CRS-Master
: 1. The MEL is an excimer laser for the refractive surgery (LASIK and PRK)
2. Treatment planning station for MEL80/MEL 90,
Dose: NA,
Frequ
Sponsors
Carl Zeiss Meditec Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and Female subjects of age between 18 to 40 years old 2. Scheduled to undergo bilateral LASIK surgery for myopia or myopic astigmatism 3. Preoperative corrected distance visual acuity of 20/20 Snellen or better in each eye 4. Normal corneal topography in each eye 5. Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination 6. Preoperative corneal astigmatism less than or equal to 2 D in each eye 7. Corneal astigmatism and refractive cylinder are with 0.50 D and axis within 10° 8. Preoperative corneal higher order aberrations (HOA) RMS less than or equal to 0.4 microns in each eye 9. Preoperative whole eye higher order aberrations (HOA RMS less than or equal to 0.5 microns measured at a 6 mm pupil diameter in each eye 10. Angle kappa less than or equal to 5 degrees in each eye 11. Residual stromal thickness greater than or equal to 280 microns in each eye 12. Availability, willingness, to comply with examination follow up visits 13. Signed informed consent and data protection documents
Exclusion criteria
Exclusion criteria: 1. Irregular corneal astigmatism in each eye 2. Ocular surface disease in each eye 3. History of ocular surgery, ocular pathology, or other significant ocular findings that, in the investigator’s opinion, may increase the patient’s risk for corneal refractive surgery or affect potential visual outcomes in each eye 4. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc,) in each eye 5. Amblyopia, strabismus, nystagmus, forme fruste keratoconus in each eye 6. Clinically significant pupil abnormalities in each eye 7. Desire for monovision correction 8. Use of systemic or ocular medications that may affect visual outcomes 9. Systemic pathology that may affect the results of the study 10. Pregnancy or being treated for conditions associated with hormonal fluctuations 11. Participation in another clinical trial in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuities, Refractive outcomes, Corneal high-order aberrations, Patient questionnaire. Timepoint: Preoperative, Operative, 1-day, 1-Month, and 3-Months postoperative. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NIL | — |
Countries
India, Malaysia
Contacts
Public ContactDr Sandeep Singh
CBCC Global Research LLP
Outcome results
None listed