MedPath

Evaluation of change in ability of both eyes to focus simultaneously and muscle balance of eye before and after Relex® Smile refractive surgical procedure to correct short sightedness.

Not Applicable
Conditions
Health Condition 1: null- Healthy individuals with short sightedness for refractive procedures.
Registration Number
CTRI/2015/06/005922
Lead Sponsor
ethradhama Superspeciality Eye Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
50
Inclusion Criteria

1.21 to 40 years of age

2.Myopia upto10 Ds and astigmatism upto â??5 D.

3.Stable corneal conditions within the last 12 months

4.Stable refraction since past 12 months ( <0.5D change within past 12 months)

5.Healthy ocular surface with stable tear film

6.Discontinuation of soft contact lenses 1 week, and rigid contact lenses 3 weeks prior to surgery.

7.Willing to participate in study with assured follow up

Exclusion Criteria

1.Corneal ecstatic diseases such as Keratoconus suspects or frank keratoconus, keratoglobus, Pellucid Marginal Degeneration.

2.Mixed astigmatism, hyperopia.

3.Moderate to severe dry eye.

4.Socket / globe /lid anomalies, very deep set eyes, nanophthalmos.

5.Severe meibomian gland disease, lid abnormalities.

6.Severe atopy.

7.Contact lens warpage on topography.

8.Severe Contact lens induced ocular allergy.

9.Pregnant and nursing mother.

10.Patients having collagen vascular disease.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in binocular vision and ocular alignment parameters before and after RELEX SMILE.Timepoint: Day 15 and 3 months after surgery.
Secondary Outcome Measures
NameTimeMethod
To compare computer orthoptic diagnostics (VTS4) with conventional orthoptic diagnostic methods to evaluate ocular alignment and binocular vision.Timepoint: preop, day1, day15 and 3 month.
© Copyright 2025. All Rights Reserved by MedPath