Subjective iris matching for adjustment of torsional errors instead of conventional manual limbal marking in refractive surgery with SMILE using Visumax 800

Subjective iris matching for cyclotorsion adjustment in myopic astigmatism correction with SMILE using Visumax 800 - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068316

Enrollment

Registered

2024-06-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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 Health Condition 2: H521- Myopia

Interventions

Intervention1: Myopic astigmatism correction with SMILE using Visumax 800: Refractive lenticule extraction to correct refractive errors using femtosecond laser technology. Femtosecond laser procedure

Eligibility

Inclusion criteria

Inclusion criteria: 1.Myopia between -3.00 and -8.00 DS, astigmatism more than or equal to -0.75 DC undergoing SMILE with Visumax 800 2.Stable corneal conditions within last 12 months 3.Stable refraction since past 12 months 4.Healthy ocular surface with stable tear film 5.Discontinuation of soft contact lenses 1 week, and rigid contact lenses 3 weeks prior to surgery 6.Subjects willing and able to understand and sign informed consent. 7.Subjects willing and able to attend postoperative examinations per protocol schedule.

Exclusion criteria

Exclusion criteria: 1.Thin corneas 2.Steep corneas 3.Keratoconus suspects or frank keratoconus 4.Mixed astigmatism 5.Moderate to severe dry eyes 6.Socket/globe/lid anomalies- very deep set eyes, nanophthalmos 7.Severe meibomian gland disease , lid abnormalities 8.Severe atopy 9.Contact lens overuse 10.Pregnant and nursing mothers 11.Patients on systemic medications

Design outcomes

Primary

Measure	Time frame
Complete refractive error correction. Patent will be spectacle free on the same day of surgery. Patient should visit 3 times for followup to check for any residual refraction.Timepoint: Postoperative day 1, 2 weeks and 3 months followup 1.Uncorrected distance visual acuity on day 1, 2 weeks, 3 months 2.Best corrected visual activity on 1 day, 2 weeks and 3 months 3.Topography- Pentacam- Keratometry values	—

Measure

Time frame

Complete refractive error correction. Patent will be spectacle free on the same day of surgery. Patient should visit 3 times for followup to check for any residual refraction.Timepoint: Postoperative day 1, 2 weeks and 3 months followup 1.Uncorrected distance visual acuity on day 1, 2 weeks, 3 months 2.Best corrected visual activity on 1 day, 2 weeks and 3 months 3.Topography- Pentacam- Keratometry values

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Secondary

Measure	Time frame
No residual refractive error is expected after cyclotorsion correction. Post operative evaluation on 3 occassions is mandatory to prove the feasiblity of the technique used in this studyTimepoint: Postoperative examinations : will be performed on 1 day, 2 weeks & 3 months followup: 1.Uncorrected distance visual acuity on day 1, 2 weeks, 3 months 2.Best corrected visual activity on 1 day, 2 weeks & 3 months 3.Topography- Pentacam- Keratometry values	—

Measure

Time frame

No residual refractive error is expected after cyclotorsion correction. Post operative evaluation on 3 occassions is mandatory to prove the feasiblity of the technique used in this studyTimepoint: Postoperative examinations : will be performed on 1 day, 2 weeks & 3 months followup: 1.Uncorrected distance visual acuity on day 1, 2 weeks, 3 months 2.Best corrected visual activity on 1 day, 2 weeks & 3 months 3.Topography- Pentacam- Keratometry values

—

Countries

India

Contacts

Public ContactLinto Mathew Thomas

Nethradhama superspeciality eye hospital

bhayanidrjanki@gmail.com7357759879

Outcome results

None listed

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