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Initial outcomes of CLEAR procedure

A study to assess clinical performance and visual outcome of Klex using the Ziemer FEMTO LDV Z8 Platform (CLEAR) - nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085588
Enrollment
50
Registered
2025-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: H189- Unspecified disorder of cornea

Interventions

Intervention1: visual outcome of Klex using the Ziemer FEMTO LDV Z8 Platform (CLEAR): The CLEAR procedure employs the Zeimer Z8 femtosecond laser to create a refractive lenticule within the corneal st

Sponsors

Nethradhama superspeciality eye hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with simple myopia and myopic astigmatism Manifest spherical equivalent -10 D or less Manifest cylinder 3 D or less SE difference of 2 D or less between 2 eyes Stable refraction (less than 0.50 D change in past 1 year) Best spectacle corrected visual acuity of 6 by 6 or better in both eyes No evidence of irregular astigmatism on corneal topography in both eyes Residual stromal bed thickness 280 micrometer or more

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To assess clinical performance and visual outcomes of Keratorefractive Lenticule Extraction Using the Ziemer FEMTO LDV Z8 Platform (CLEAR)Timepoint: post op day 1,14 and 90

Secondary

MeasureTime frame
nilTimepoint: nil

Countries

India

Contacts

Public ContactDrFaiza Syed Jafar

Nethradhama Super Speciality Eye Hospital

dr.supriyasriganesh@nethradhama.org8951027740

Outcome results

None listed

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