Comparison of visual outcomes of SMILE surgery performed for high myopic astigmatism using a software with Visumax 800(a new laser machine) versus manual technique used with Visumax 500(another laser machine)

Not yet recruiting

• Conditions: Astigmatism,

• Registration Number: CTRI/2022/02/040417
• Lead Sponsor: CARL ZEISS MEDITEC

Brief Summary

To evaluate the visual and refractive outcomes of SMILE surgery performed for high myopic astigmatism (>/= 1.5 D) using OcuLign software and the results will be compared with VIsual and refractive outcomes of SMILE surgery performed for high astigmatism using Manual cyclotorsion compensation used with Visumax500 laser machine. A total of 50 eyes treated with Visumax800 satisfying inclusion criteria will be taken into study.Post-operatively this data will be analysed with a retrospective data of another 50 eyes from 50 patients who underwent SMILE for myopic astigmatism treated with manual compensation using ink marking method with the visumax500 femto laser.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-17
• Study Start: 2022-02-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1)SE between -1D to -10D 2)Astigmatism upto -5D.

Exclusion Criteria

1)keratoconus 2)Pellucid marginal degeneration or suspect cornea 3)severe dry eye or meibomian gland disease 4)glaucoma 5)retinal diseases 6)pregnancy 7)patients on immunosupressants 8)patients with unassured follow up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the outcomes of astigmatism correction with the use of OcuLign software in Visumax800	1)post-op day1 | 2)post-op day7 | 3)post-op day180

Secondary Outcome Measures

Name	Time	Method
To evaluate safety and efficacy of OcuLign software in Visumax 800	1)post day1

Trial Locations

Locations (1)

Nethradhama Superspeciality Eye Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Nethradhama Superspeciality Eye Hospital

🇮🇳Bangalore, KARNATAKA, India

Dr Sheetal Brar

Principal investigator

9591002092

brar_sheetal@yahoo.co.in