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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.

Evaluation of ocular alignment and binocular vision before and after RELEX® SMILE for correction of myopia and myopic astigmatism.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/06/005922
Enrollment
50
Registered
2015-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Healthy individuals with short sightedness for refractive procedures.

Interventions

None listed

Sponsors

Nethradhama Superspeciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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 ( 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

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.

Design outcomes

Primary

MeasureTime frame
Changes in binocular vision and ocular alignment parameters before and after RELEX SMILE.Timepoint: Day 15 and 3 months after surgery.

Secondary

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDr Sri Ganesh

Nethradhama Superspeciality eye hospital

drrahulp2012@gmail.com9731809663

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026