Analysis of results achieved and experience of trainee refractive surgeons in learning SMILE pro surgery for minus power correction using VISUMAX 800 laser

Analysis of Initial Clinical Outcomes and Performance in Lenticule Extraction with SMILE Pro Performed by Refractive Surgeons Training in SMILE Pro Using the VISUMAX 800

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/099788

Enrollment

Registered

2025-12-24

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SMILE Pro: It is flapless and minimally invasive form of laser vision correction for surgical myopia correction Intervention2: Nil: Nil Control Intervention1: Nil: No comparator agent

Eligibility

Inclusion criteria

Inclusion criteria: Stable refraction Myopia between -1 to -10 SE Astigmatism within 5 D Suitable topography Healthy ocular surface Healthy optic nerve and retina

Exclusion criteria

Exclusion criteria: severe dry eye keratoconus ocular infections pregnancy immunosuppession

Design outcomes

Primary

Measure	Time frame
post op uncorrected visual acuityTimepoint: post op day 1 and 3 weeks	—

Secondary

Measure	Time frame
Docking time: Time from insertion of the eye speculum to laser activation (minutes). The time will be taken using a stopwatch and recorded by the same person. - Docking success rate: Percentage of eyes achieving successful docking and challenges encountered. - Lenticule dissection and extraction time: Time required to dissect and remove the lenticule (minutes). - Total surgical time: Time from speculum insertion to removal for one eye (minutes). -ComplicationsTimepoint: Intra-operative	—

Measure

Time frame

Docking time: Time from insertion of the eye speculum to laser activation (minutes). The time will be taken using a stopwatch and recorded by the same person. - Docking success rate: Percentage of eyes achieving successful docking and challenges encountered. - Lenticule dissection and extraction time: Time required to dissect and remove the lenticule (minutes). - Total surgical time: Time from speculum insertion to removal for one eye (minutes). -ComplicationsTimepoint: Intra-operative

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Countries

India

Contacts

Public ContactSheetal Brar

ProSight Eye Hospital

sheetalbrar1@gmail.com9591002092

Outcome results