Comparison of outcomes and patient satisfaction between three procedures for correction of low to moderate short sightedness

Not Applicable

• Conditions: Health Condition 1: null- patients with healthy eyes besides low to moderate myopic astigmatism

• Registration Number: CTRI/2014/04/004537
• Lead Sponsor: ethradhama Research Foundation

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: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

ICL group A:

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

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 â?? 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified