Comparison of the post operative Quality of vision using Objective Scatter Index following SMILE correction versus EYECRYL Phakic Intraocular lenses for correction of high myopia and astigmatism.

Comparison of the post operative Objective Scatter Index and quality of vision following SMILE versus EYECRYL Phakic Intraocular lenses for correction of high myopia and astigmatism. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064156

Enrollment

Registered

2024-03-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: SMILE-Pro CORRECTION: SMILE-Pro correction as a cornea based approach for correction of high myopia and astigmatism The whole procedure including the pre and post operative monitoring

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with simple myopia or myopic astigmatism. 2. Ages : 21-40 years . 3. Manifest spherical equivalent between -6 and -10 D for SMILE correction and between -6 to -23 D for phakic IOL implantation with/without a manifest cylinder of -5 D or less for both groups. 4. Stable refraction ( 5. Corrected distant visual acuity (CDVA) of 6/6 or better in both eyes in SMILE correction and 6/9 or better in phakic IOL group. 6. No evidence of irregular astigmatism on corneal topography in both eyes . 7. Residual stromal bed thickness (RSBT) – 280 µm or more for SMILE correction. 8. Anterior chamber depth of 2.8 or more in the phakic IOL group. 9. Endothelial cell count of 2500 cells/mm3 or more in the phakic IOL group. 10. Ability to understand and willingness to sign inform consent to participate in follow-ups

Exclusion criteria

Exclusion criteria: 1. Kerato-ectatic conditions such as keratoconus, keratoconus suspects, pellucid marginal degeneration etc. 2. Patients having hypermetropia, mixed astigmatism with presbyopia. 3. Patients who have undergone any refractive procedure previously. 4. Anisometropia of 2D or more . 5. Amblyopia . 6. Progressive or unstable myopia and /or astigmatism. 7. History of ocular surgery, severe dry eye , corneal degeneration , corneal dystrophy, cataract , uveitis, retinal pathology . 8. Concurrent use of medication likely to affect interface healing. 9. Previous history of ocular trauma. 10. Immunocompromised state / pregnancy / nursing mothers/ cancer patients.

Design outcomes

Primary

Measure	Time frame
b.Uncorrected Distance Visual Acuity(UDVA) c.Corrected Distance Visual Acuity(CDVA) d.Manifest Spherical Equivalent refraction ( SE) e.Undilated anterior segment clinical photograph in the phakic IOL group. f.Pentacam g.MS-39 & NIBUT h.Optical Quality (OQAS –HD ANALYZER ) for OSI i.i-Trace for total HOA, SA & coma at 4 mm scan size j.Treatment decentration if any in the SMILE group. Timepoint: Baseline, 1 day, 2 weeks and 3 months	—

Measure

Time frame

b.Uncorrected Distance Visual Acuity(UDVA) c.Corrected Distance Visual Acuity(CDVA) d.Manifest Spherical Equivalent refraction ( SE) e.Undilated anterior segment clinical photograph in the phakic IOL group. f.Pentacam g.MS-39 & NIBUT h.Optical Quality (OQAS –HD ANALYZER ) for OSI i.i-Trace for total HOA, SA & coma at 4 mm scan size j.Treatment decentration if any in the SMILE group. Timepoint: Baseline, 1 day, 2 weeks and 3 months

—

Secondary

Measure	Time frame
Patient satisfactionTimepoint: Baseline, 1 day, 2 weeks & 3 months	—

Countries

India

Contacts

Public ContactDr Sanjita Mishra

Nethradhama Super specialty Eye Hospital, Bengaluru

sanjitamishra11@gmail.com7205842655

Outcome results

None listed

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