Trials / Unknown
UnknownNCT03431571
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 374 (actual)
- Sponsor
- Carl Zeiss Meditec AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
Detailed description
The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ReLEx SMILE | the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea |
Timeline
- Start date
- 2017-07-05
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2018-02-13
- Last updated
- 2020-02-24
Locations
8 sites across 6 countries: China, Czechia, France, Germany, India, United Kingdom
Source: ClinicalTrials.gov record NCT03431571. Inclusion in this directory is not an endorsement.