Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Other | ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReLEx SMILE | Procedure | the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corrected Distance Visual Acuity (CDVA) | CDVA in logMar | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| side effects | distribution in percent | 12 months |
| contrast sensitivity | contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Walter Sekundo | Uniklinikum Gießen Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Shanghai | Shanghai | China | ||||
| Tianjin Eye Hospital, Heping District |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| patient satisfaction (Quality of Vision Questionnaire) | Mean +/- standard deviation | 12 months |
| manifest refractive astigmatism | Astigmatism in diopters [D] | 12 months |
| spherical equivalent (SE) | SE in diopters [D] | 12 months |
| Tianjin |
| China |
| Gemini Eye Clinic | Zlín | Czechia |
| University Medical Center CHRU Brest | Brest | France |
| Medical Center Heliosklinikum | Erfurt | Germany |
| University Medical Center Universitätsklinikum Gießen Marburg | Marburg | Germany |
| Medical Center Nethradhama Superspeciality Eye Hospital | Bangalore | India |
| London Vision Clinic | London | United Kingdom |