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

Phase 2

• Conditions: Health Condition 1: O- Medical and SurgicalHealth Condition 2: H521- Myopia

• Registration Number: CTRI/2024/06/068316
• Lead Sponsor: I

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified