NCT04426175

Z8 OCT-controlled 2D vs 3D LASIK

Precision of 2D vs 3D Low Energy Femto-LASIK: Intraoperative and Postoperative OCT-based Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Zentrumsehstarke Hamburg · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications and how it correlated to visual experience and quality of life responses during the early postoperative period.

Detailed description

It has been postulated that it is possible with the Ziemer Femtosecond LDV laser system to create reproducible flaps in terms of thickness and predictability. The aim of this study was to test the hypothesis that OCT-guided 110 µm targeted flaps will result in accurate, predictable, and precise thickness flaps, with low complication rates when performed and compared using both 2D and 3D flap geometry applications. Patient-reported outcomes are increasingly incorporated into clinical trials as they provide access to valuable information on the physical experience of the patient during and after the treatment. A questionnaire will therefore also be introduced in this study to evaluate how well self-reported pain, visual experience, and quality of life responses are correlated with flap geometries in both groups during the early postoperative period. The study holds direct medical benefit to the patient in this that they received an immediate improvement in his/her unaided vision. Moreover, the patient's participation contributes to the medical knowledge about the use of femtosecond lasers for refractive surgery, in particular in view of the use of intraoperative OCT visualization tools. The patients will gain access to the newest technology available for refractive surgery namely a low pulse energy high-frequency femtosecond laser.

Conditions

• Myopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting	2D and 3D cutting methods were randomly used in same subjects

Timeline

• Start date: 2019-12-05
• Primary completion: 2020-04-23
• Completion: 2020-04-23
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

1 site across 1 country: Germany