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ReLEx SMILE LASER SURGICAL PROCEDURE FOR CORRECTION OF MYOPIA WITH WASH GIVEN IN ONE EYE AND NO WASH IN OTHER EYE

COMPARATIVE STUDY OF PATIENTS WHO UNDERWENT RELEX SMILE WITH ONE EYE INTERFACE WASH AND CONTRALATERAL EYE WITHOUT WASH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/04/004561
Enrollment
20
Registered
2014-04-23
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- myopia or myopic astigmatism

Interventions

Intervention1: INTERFACE WASH WITH BALANCED SALT SOLUTION: INTRAOPERATIVELY, DURING RELEX SMILE SURGERY FOLLOWING REMOVAL OF LENTICULE, INTRASTROMAL CORNEAL POCKET (INTERFACE) WAS WASHED FOR A PERIOD

Sponsors

Nethradhama Superspeciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 40 eyes of 20 patients with myopia or myopic astigmatism upto -10.0D spherical equivalent will be included in this study. Inclusion criteria : 1) Stable refraction for atleast 1 year 2) Soft contact lens discontinued for minimum 1 week and rigid gas permeable contact lens discontinued for minimum 3 weeks 3) Corneal topography-minimum corneal thickness 480µ, residual corneal thickness atleast 250µ/50% of original thickness (whichever is higher)

Exclusion criteria

Exclusion criteria: Evidence of ocular diseases like: 1)Meibomian gland diseases 2)Herpetic keratitis, 3)Uvietis 4)Glaucoma 5)Visually significant cataract 6)Retinal diseases like retinal dystrophies or diabetic retinopathy 7)Progressive myopia and/or astigmatism 8)Pathologies of cornea like corneal dystrophies, keratoconus, any history of corneal trauma or surgery within flap zone 9)Dry eyes - Schirmerâ??s 2 test value less than 10 mm, 11)Taking any systemic medication likely to affect wound healing like corticosteroids or antimetabolites, 12)History of immunocompromised state or pregnancy or nursing mothers .

Design outcomes

Primary

MeasureTime frame
postoperative uncorrected visual acuity(Snellens), contrast sensitivity using Functional acuity contrast test(F.A.C.T)chart, and root mean square(RMS) of higher order aberrations(HOA)in microns using ray tracing technology(itrace)Timepoint: postoperative day 1 and day 15

Secondary

MeasureTime frame
score obtained from subjective questionnaire : pain, pricking sensation, redness, watering, glare, and patient satisfactionTimepoint: day 1 and day 15

Countries

India

Contacts

Public ContactRishika Gupta

Nethradhama SuperSpeciality Eye Hospital

rishikagupta55@yahoo.com09886309097

Outcome results

None listed

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