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Comparison of time taken for SMILE surgery of both eyes performed with 2 different machines

Comparison of intra-operative time taken for docking, lenticule dissection and overall workflow for bilateral SMILE performed with VisuMax 800 versus VisuMax 500.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047703
Enrollment
60
Registered
2022-11-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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: 30 pateints undergoing bilateral RELEX SMILE procedure on VisuMax 800 over 6 months: Intraoperative time taken for docking, lenticule dissection and overall workflow is recorded Control

Sponsors

Carl Zeiss Meditech
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: age >21 years to 40 years, pre-op myopia or myopic astigmatism with SE between -1.00 to -10.00 D and manifest cylinder < 1.50 D ( not requiring limbal marking)

Exclusion criteria

Exclusion criteria: Refractive cylinder >1.5 D, keratoconus, pellucid marginal degeneration or suspect cornea, severe dry eye or meibomian gland disease, glaucoma or retinal disease, pregnancy, patients on immunosuppressants and patients with unassured follow ups.

Design outcomes

Primary

MeasureTime frame
to compare the time to perform different steps of the same procedure between 2 machinesTimepoint: intraoperative time—

Secondary

MeasureTime frame
to assess uncorrected and corrected distance visual acuity, subjective refraction and optical scatter index of both eyesTimepoint: post operative day 1—

Countries

India

Contacts

Public ContactDr Sindhu Bhargav

Nethradhama Superspeciality Eye Hospital, Bangalore

brar_sheetal@yahoo.co.in9591002092

Outcome results

None listed

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