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COMPARISON OF FEASIBILITY, SAFETY AND OUTCOMES OF SMILE PROCEDURE WITH SMALLER THAN NORMAL VERSUS NORMAL SIDECUT USING AN ADVANCED FEMTOLASER SYSTEM

FEASIBILITY, SAFETY AND OUTCOMES WITH SUB 10u SIDE CUT PATTERNS USING A 2 MHZ FEMTOLASER IN EYES UNDERGOING SMILE - A CONTRALATERAL EYE STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033235
Enrollment
102
Registered
2021-04-29
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: O- Medical and Surgical

Interventions

Intervention1: LENTICULE SIDE CUT: 10 MICRON SIDE CUT Control Intervention1: LENTICULE SIDE CUT: 1, 3, 5 MICRON SIDE CUTS

Sponsors

Research Foundation Nethradhama Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with simple myopia and myopic astigmatism 2. Age : 21-40 years 3. Manifest spherical equivalent - 10 D or less 4. Manifest cylinder 3 D or less 5. SE difference of 2 D or less between 2 eyes 6. Stable refraction ( 7. Best spectacle corrected visual acuity (BSCVA) of 6/6 or better in both eyes 8. No evidence of irregular astigmatism on corneal topography in both eyes 9. Residual stromal bed thickness (RSBT) â?? 280 µm or more 10. Ability to understand and willingness to sign inform consent to participate in follow-ups

Exclusion criteria

Exclusion criteria: 1. Kerato-ectatic conditions such as keratoconus, keratoconus suspects, pellucid marginal degeneration etc 2. Patients having hypermetropia, mixed astigmatism with Presbyopia. 3. Patients who have undergone any refractive procedure previously. 4. Anisometropia of 2D or more 5. Amblyopia 6. Progressive or unstable myopia and /or astigmatism 7. History of ocular surgery, severe dry eye , corneal degeneration , corneal dystrophy, cataract , uveitis, retinal pathology 8. Concurrent use of medication likely to affect interface healing 9. Immunocompromised state / pregnancy / nursing mothers/ cancer patients

Design outcomes

Primary

MeasureTime frame
feasibility, safety, and ease of lenticule dissection with sub 10 microns side cut enabled using a high frequency (2 MHz), low energy VisuMax femtolaser system and compare the same with 10 microns side cut SMILE procedure in eyes undergoing bilateral SMILE for myopia or myopic astigmatism correction.Timepoint: POST-OP 1 DAY, 2 WEEKS, AND 3 MONTHS—

Secondary

MeasureTime frame
To compare the visual and refractive outcomes including immediate visual acuity, optical quality, contrast sensitivity, corneal biomechanics and patient satisfaction between the two groups of side cut patterns (sub-10 microns versus 10 microns).Timepoint: POST-OP 1 DAY, 2 WEEKS, AND 3 MONTHS—

Countries

India

Contacts

Public ContactSheetal Brar

NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL,BANGALORE

brar_sheetal@yahoo.co.in09591002092

Outcome results

None listed

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