Results of ReLEx SMILE technique for short sight correction after compensating for eye rotation

Active, not recruiting

• Conditions: Healthy individuals undergoing ReLEx SMILE for correction of myopic astigmatism

• Registration Number: CTRI/2014/04/004570
• Lead Sponsor: Nethradhama Eye Hospital

Brief Summary

The refractive outcome of astigmatism correction has been shown to depend on the accuracy of the axis treatment as any rotational movement of the eyes during treatment may cause shift in the treatment axis leading to undesirable results like undercorrection and induction of aberrations. Most of the currently available excimer laser platforms have the ability to detect and compensate for the static and dynamic cyclotorsion due to positional changes and treatment by advanced softwares and eye tracking. The Visumax femtolaser system at present does not have this feature , hence there is no method is described to compensate for rotational movement during the procedure. Through this study , we describe a method for the compensation of static cyclotorsional movements during ReLEx SMILE procdure in patients with myopic astigmatism (>0.75D), and study the reliability and efficacy of this technique in terms of cylindrical correction and post operative refractive outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-03
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Total number of eyes enrolled in the study will be 60 Patients of both sex, within the age group 21 – 40 years suitable for correction with ReLEx SMILE and who have healthy eyes besides- 1.myopic astigmatism of any degree with manifest cylinder > -0.75 D 2.
• Adequate Corneal pachymetry (> 480 D) 3.

Exclusion Criteria

• 1.Myopic refractive error with manifest cylinder < -0.75 D or > -5 D 2.Hyperopic astigmatism 3.Irregular astigmatism 4.Inadequate Corneal pachymetry (<480 u) 5.
• K max >48 D 6.Evidence of keratoconus on corneal topography 7.External ocular disease- severe meibomian gland disease, severe contact lens induced allergy 8.Corneal scars or dystrophies 9.Socket / globe /lid anomalies – very deep set eyes, nanophthalmos 10.Severe meibomian gland disease, lid abnormalities 11.Severe atopy 12.Contact lens overuse 13.Pregnant and nursing mother 14.Pts on systemic medications eg Iso retinoic acid, hormonal preperations, OCPs, antidepressants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of astigmatism correction and residual cylinder post operatively	post op day 1, day 15 and 3 month

Secondary Outcome Measures

Name	Time	Method
change in topographic cylinder	post op day 1, day 15 and 3 month

Trial Locations

Locations (1)

Nethradhama Superspeciality Eye Hospital, Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Nethradhama Superspeciality Eye Hospital, Bangalore

🇮🇳Bangalore, KARNATAKA, India

Dr Sheetal Brar

Principal investigator

9591002092

brar_sheetal@yahoo.co.in