“Matched population comparison of visual outcomes and patient satisfaction between three treatments modalities for the correction of low to moderate myopia and myopic astigmatismâ€
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Efficacy, predictability, stability and safety variables (efficacy and safety indexes) and stability over-time
Study Overview
Brief Summary
For appx two decades, photorefractive keratectomy (PRK) and Laser in situ keratimilieusis (LASIK) have been used to correct myopia. However, both procedures have shown to cause some instability of cornea and induction of aberrations for higher powers (>6 D) in long term studies. With the introduction of femtolasers, it is believed that the surgery is more precised and predictable. Neverthless, LASIK always entails the risk of flap related complications , delayed healing , induction of aberrations, night vision problems and ectasia in future.
With further advancement in technology, we now have alternative options for traeting myopia which are shown to be equivalent or better than the gold standard LASIK. Implantable Collamer Lens(ICL) has been proposed to be a valid option for traeting myopia outside the range of LASIK( > 12 D) and in patients with inadequate corneal thickness or who are unsuitable for keratorefractive procedures.
Another technique which is relatively recent compared to LASIK ans ICL, is the flapless all femtosecond procedure ReLEx SMILE , is proposed to be effective in treating myopia upto 10 D, with astignatism upto 5 D.
This study will be undertaken to compare the three currently available modalities ie- ICL, FEMTO LASIK and ReLEx SMILE, for correction of low to moderate myopia and study the long term visual outcomes , safety , efficacy and patient satisfaction in each of the three groups.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 21.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ICL group A: Inclusion criteria: Any gender, 21 to 45 years of age ACD (endo) ≥ 3mm Myopia between -3 to -8 D and astigmatism between upto -3D Stable corneal conditions within the last 12 months FEMTO-LASIK group B: Inclusion criteria Any gender between 21 to 45 years of age Myopia between -3 to -8 D and astigmatism upto.
- •3 Dcyl Stable corneal conditions within the last 12 months Stable refraction since past 12 months(<0.5D change within past 12 months) Healthy ocular surface with stable tear film Discontinuation of Soft contact lenses 1 week , and rigid contact lenses 3 weeks prior to surgery SMILE group C: Inclusion criteria Any gender , 21 to 45 years of age Myopia between -3 to -8 D and astigmatism upto.
- •3 Dcyl Stable corneal conditions within the last 12 months Stable refraction since past 12 months(<0.5D change within past 12 months) Healthy ocular surface with stable tear film Discontinuation of Soft contact lenses 1 week , and rigid contact lenses 3 weeks prior to surgery.
Exclusion Criteria
- •Exclusion criteria: Age of less than 21 or more than 45 years.
- •ACD (endo) < 3 mm Myopia outside -3 to -8 D range or astigmatism > 3 D Keratoconus Cataract or glaucoma Pregnant or nursing mothers Abnormal endothelial cell count Irido-corneal angles less than Grade III Exclusion criteria- applicable to both F-LASIK and SMILE groups Myopia > -8 D SE and Manifest cylinder > 5D Thin corneas ( Corneal pachymetry <480u) Steep corneas Kmax >48 D Keratoconus suspects o r frank keratoconus Mixed astigmatism Moderate to severe dry eye(Shirmers1 <10 mm) Socket / globe /lid anomalies – very deep set eyes, nanophthalmos Severe meibomian gland disease, lid abnormalities Severe atopy Contact lens overuse Pregnant and nursing mother Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants.
Outcomes
Primary Outcomes
Efficacy, predictability, stability and safety variables (efficacy and safety indexes) and stability over-time
Time Frame: post op day 1, day 15, 3 months, 6 months, 12 months
Secondary Outcomes
- Evaluation of contrast sensitivity(Aberrations)