Skip to content

Study for comparison between two types of refractive surgeries(for spectacle removal) one involving creating a flap in cornea(black part of eye)-lasik and one without a flap- ReLEx SmILE

Comparative study of visual outcome between femtosecond lasik with excimer laser and all femtosecond ReLEx small incision lenticule extraction(SmILE)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/09/005040
Enrollment
100
Registered
2014-09-19
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 Patients with Short Sightedness

Interventions

Intervention1: LASIK-Laser Assisted in situ Keratomileusis , SMILE - Small Incission Lenticule Extraction: PARAMETERS-PRE OP VISUAL ACUITY, CONTRAST SENSITIVITY, DRY EYE, CORNEAL TOPOGRAPHY, PAIN, SAT

Sponsors

Nethradhama Superspeciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •SINGLE SURGEON •MYOPIA BETWEEN 1D TO 10D SPHERICAL EQUIVALENT/AMOUNT OF ASTIGMATISM LESS THAN 5D •AGE ABOVE 21 YEARS AND LESS THAN 40 YEARS. •STABLE REFRACTION FOR ATLEAST 6MNTHS- 1 YEAR •SOFT CONTACT LENS DISCONTINUED FOR MINIMUM 1 WEEK AND RIGID GAS PERMEABLE CONTACT LENS DISCONTINUED FOR MINIMUM 3 WEEKS •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 MEIBOMIAN GLAND DISEASES, HERPETIC KERATITIS, UVIETIS, GLAUCOMA, VISUALLY SIGNIFICANT CATARACT, RETINAL DISEASES LIKE RETINAL DYSTROPHIES OR DIABETIC RETINOPATHY. •PROGRESSIVE/UNSTABLE MYOPIA AND/OR ASTIGMATISM •ANY PATHOLOGIES OF CORNEA LIKE CORNEAL DYSTROPHIES INCLUDING KERATOCONUS,ANY H/O CORNEAL TRAUMA OR SURGERY WITHIN FLAP ZONE •DRY EYE STATUS-SCHIRMERâ??S 2 TEST VALUE LESS THAN 10 mm •OCULAR MEDICATION LIKE β BLOCKERS. •TAKING ANY SYSTEMIC MEDICATION LIKELY TO AFFECT WOUND HEALING LIKE CORTICOSTEROIDS OR ANTIMETABOLITES. •H/O IMMUNOCOMPROMISED STATE OR PREGNANCY OR NURSING MOTHERS

Design outcomes

Primary

MeasureTime frame
To compare-visual outcome;dry eye status;corneal topography;contrast sensitivity;subjective pain assessment and patient satisfaction between the two proceduresTimepoint: DAY 1,15 AND 90.

Secondary

MeasureTime frame
ANY COMPLICATIONS OF SURGERYTimepoint: DAY 1, 15 AND 90

Countries

India

Contacts

Public ContactDrSri Ganesh

Nethradhama Superspeciality Eye Hospital

akankshabatra5@gmail.com9986943464

Outcome results

None listed

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