ASIK vs SMILE

Not Applicable

• Conditions: Health Condition 1: null- Myopia and Astigmatism

• Registration Number: CTRI/2017/01/007724
• Lead Sponsor: Alcon laboratories India pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

Ocular criteria must be met in both eyes.

1. Subjects 18 years of age or older.

2. Able to comprehend and sign an informed consent form (ICF).

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.

Exclusion Criteria

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 (SQDES).

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 Design: Not specified