Comparing two laser procedures for treating myopia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study compares two laser corrective procedures for myopia: the novel CLEAR technique and the established SMILE procedure. Participants will be randomized to receive CLEAR in one eye and SMILE in the other, allowing for direct comparison of outcomes. The study will evaluate refractive predictability, clinical dry eye outcomes, changes in tear proteins, and corneal nerve changes over a 12-month period. Additionally, the metabolomic features of the removed corneal tissue and laser centering precision will be assessed to determine the effectiveness of each procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \>/= 21 years of age and \</= 50 years of age.
* Cycloplegic spherical equivalent of \>-1.00D
* Refractive cylinder -2.00 D or less; anisometropia \<1.00D
* Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.
* Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.
* Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
* No evidence of irregular astigmatism on corneal topography.
* Available to attend post-operative examinations for a 12-month period.

Exclusion Criteria:

* Progressive or unstable myopia and/or astigmatism.
* Clinical or corneal topographic evidence of keratoconus.
* Patients who want bilateral SMILE procedure
* Patients who want extracted corneal lenticule to be stored for future refractive surgery.
* Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease.
* Previous corneal surgery or trauma within the corneal treatment zone.
* Corneal vascularisation within 1mm of the corneal treatment zone.
* Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.
* Systemically immunocompromised.
* Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.
* Pregnant or nursing.

Where it's running

• Singapore National Eye Centre
  Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Jodhbir S Mehta, MD, FRCS — Singapore National Eye Centre
• Study coordinator: Jodhbir S Mehta, MD, FRCS
• Email: jodhbir.s.mehta@singhealth.com.sg
• Phone: 6322 7478

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.