LASIK vs SMILE

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/01/007724
• Date of registration: 19-01-2017
• Prospective Registration: Yes
• Primary sponsor: Alcon laboratories India pvt Ltd
• Public title: LASIK vs SMILE
• Scientific title: Comparison of Topography Guided LASIK with WaveLight EX500 to SMILE with Zeiss VisuMax
• Date of first enrolment: 31-01-2017
• Target sample size: 450
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16900
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: N/A

Countries of recruitment

Brazil, India, Mexico, Other, Singapore

Contacts

• Name: Dr Salman Anzer
• Affiliation: Alcon Laboratories Pvt Ltd (India)

• Name: Dr Salman Anzer
• Affiliation: Alcon Laboratories Pvt Ltd (India)

Key inclusion & exclusion criteria

Inclusion criteria: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Myopia and Astigmatism

Intervention(s)

Intervention1: WaveLight® EX500 excimer laser system: Laser in situ keratomileusis (LASIK), a refractive surgery procedure
Control Intervention1: The Zeiss VisuMax
laser keratome ophthalmic surgical laser: Small incision lenticular extraction (SMILE) is the newest refractive surgery procedure

Primary Outcome(s)

1. Percentage of eyes with manifest refraction cylinder â?¤ 0.5 D at 3 monthsTimepoint: on the day of the surgery (i.e. Visit 00)

Secondary Outcome(s)

1. Mean manifest refraction cylinder at 3 months.

2. Mean UCVA at 3 monthsTimepoint: on the day of the surgery (i.e. Visit 00)

Secondary ID(s)

RFL605-P001

Source(s) of Monetary Support

Alcon laboratories India pvt Ltd

Ethics review

Status: Approved
Approval date: 07/12/2016
Contact:

Narayana Nethralaya Ethics Committee

Status: Not Approved
Approval date:
Contact:

Insitutional Ethics Committee

Status: Not Approved
Approval date:
Contact:

Institute Ethics committee of All India Institute of Medical Sciences