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Recorrection for the patient who underwent hyperopic smile surgery with post-operation less vision

A prospective study to assess clinical performance and visual outcomes after hyperopic SMILE enhancement. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084425
Enrollment
45
Registered
2025-04-08
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: H520- Hypermetropia

Interventions

Intervention1: Refractive surgery: Based on the refractive error, corneal thickness and ocular surface parameters method of enhancement will be choosen.To the patients who are having low refractive er

Sponsors

Nethradhama Super Speciality Eye Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Residual hyperopia of more than or equal to + 0.75 D affecting visual function. Stable refraction for at least 6 months post-SMILE. Adequate corneal thickness (residual stromal bed more than or equal 280 micrometer). No signs of corneal ectasia or keratoconus. No significant ocular surface disease. No significant ocular surface disease or uncontrolled glaucoma Realistic expectations and willingness to adhere to post-op care.

Exclusion criteria

Exclusion criteria: Progressive hyperopia or unstable refraction. Irregular corneal shape (topographic signs of ectasia). Severe dry eye disease or ocular surface instability. Concurrent use of medication likely to affect interface healing Immunocompromised state/pregnancy/nursing mothers/cancer patients

Design outcomes

Primary

MeasureTime frame
Assessment of efficacy of enhancement by analysing the visual outcomeTimepoint: post op day 1,14,1 month,3 month and 6 month

Secondary

MeasureTime frame
1.To evaluate the predictability & stability of the refractive correction over time. 2.To analyze the safety profile of enhancement techniques for hyperopic SMILE, including intraoperative & postoperative complications. 3.To assess changes in corneal topography & biomechanics following enhancement. 4.To compare postoperative patient satisfaction & quality of vision before & after enhancement. Timepoint: post op day 1,14,1 month,3 month & 6 month

Countries

India

Contacts

Public ContactDrmanasaveena N T

Nethradhama Super Speciality Eye Hospital

manasa.veena2412@gmail.com9060630060

Outcome results

None listed

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