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Study to find out how soon the patient recovers the normal vision after SMILE surgery for near-sightedness.

Time course of optical quality in relation to interface healing after femtosecond laser small incision lenticule extraction (SMILE) in myopia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007788
Enrollment
50
Registered
2017-02-06
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: nil: nil Control Intervention1: nil: nil

Sponsors

Nethradhama Superspeciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age ( 18 years â?? 40 years ) 2) Unsatisfactory correction with spectacles or contact lenses 3) Manifest spherical equivalent - 10 diopters or less 4) Manifest cylinder 4 diopters or less 5) Stable refraction ( 6) Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes 7) No evidence of irregular astigmatism on corneal topography in BOTH eyes 8) Residual stromal bed thickness (RSBT) â?? atleast 300 µm 9) Ability to understand and willingness to sign inform consent 10) Willingness to participate in follow up visits

Exclusion criteria

Exclusion criteria: 1) Progressive or unstable myopia and /or astigmatism 2) Thinnest pachymetry ( 3) Endothelial cell count 4) Evidence of ocular surface diseases 5) History of ocular surgery, severe dry eye , corneal degeneration , corneal dystrophy, cataract , uveitis, retinal pathology 6) Kerato-ectatic conditions such as Keratoconus, Keratoconus suspects, Pellucid marginal deneration etc 7) Concurrent use of medication likely to affect interface healing ( corticosteroids retinoic acid and antimetabolites) 8) Immunocompromised state / pregnancy / nursing mothers/ cancer patients 9) Patients with unrealistic expectations

Design outcomes

Primary

MeasureTime frame
visual acuity, contrast sensitivity, residual refractionTimepoint: At day 1, 15th day and 3 months after procedure.

Secondary

MeasureTime frame
higher order aberrationsTimepoint: post op day 1. 15 and 3 months

Countries

India

Contacts

Public ContactDr Rahul Pandey

Nethradhama Superspeciality eye hospital

drrahulp2012@gmail.com9731809663

Outcome results

None listed

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