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Study to correlate bubble layer formed in cornea with strength of corneal layers during laser surgery for short sight.

Clinical study to evaluate the correlation of opaque bubble layer(OBL) with corneal biomechanics and densitometry in eyes undergoing SMILE for myopic correction.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/01/022842
Enrollment
200
Registered
2020-01-17
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: H521- Myopia

Interventions

Intervention1: SMILE surgery: Corneal lenticule will be removed after application of femtosecond laser. Application of laser creates opaque bubble layer, this will be correlated with corneal biomechan

Sponsors

Nethradhama superspeciality eye hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: spherical equivalent up to â??10 diopters (D) age of 21 years or older stable refraction for at least 1 year soft contact lens use discontinued for 1 week and rigid gas permeable lens use discontinued for 3 weeks prior to the procedure minimum corneal thickness of 480 μm residual stromal bed of at least 250 μm ability to understand and willingness to participate in all follow-up visits.

Exclusion criteria

Exclusion criteria: evidence of residual or active ocular diseases such as herpetic keratitis, uveitis, glaucoma visually significant cataract, retinal diseases such as retinal dystrophies or diabetic retinopathy, corneal dystrophies, keratoconus history of corneal trauma or surgery, severe dry eyes (Schirmerâ??s 2 test value use of systemic medications likely to affect wound healing (eg, corticosteroids or antimetabolites) immunocompromised state Women who are pregnant or nursing

Design outcomes

Primary

MeasureTime frame
UCVA, BCVATimepoint: Pre operative visit, post operative day 1 and day 15

Secondary

MeasureTime frame
UCVA, BCVATimepoint: Post operative day 15

Countries

India

Contacts

Public ContactDR SRI GANESH
phacomaverick@gmail.com

Outcome results

None listed

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