Status:
UNKNOWN
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
Lead Sponsor:
Carl Zeiss Meditec AG
Conditions:
Hypermetropia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 pr...
Eligibility Criteria
Inclusion
- Normal corneal topography;
- Predicted post-operative keratometry ≤51 D;
- Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
- Patients should be able to understand the patient information and willing to sign an informed consent;
- Patients should be willing to comply with all follow-up visits and the respective examinations;
- Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
- The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
- A difference between cycloplegic and manifest refractions of ≤1.00 D spherical equivalent in the eye to be treated;
Exclusion
- The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
- Mixed astigmatism
- Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
Key Trial Info
Start Date :
July 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT03431571
Start Date
July 5 2017
End Date
December 31 2020
Last Update
February 24 2020
Active Locations (8)
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1
University Medical Center Shanghai
Shanghai, China
2
Tianjin Eye Hospital, Heping District
Tianjin, China
3
Gemini Eye Clinic
Zlín, Czechia
4
University Medical Center CHRU Brest
Brest, France