Clinical trial of the femtosecond laser VisuMax for refractive correction of hyperopia by the lenticule removal
- Conditions
- H52.0
- Registration Number
- DRKS00004784
- Lead Sponsor
- Carl Zeiss Meditec AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 49
* The patient wishes the refractive correction of hyperopia
* No previouse refractive surgery
* Contact lens wearers must have removed the hard contact lenses at least 4 weeks and the soft contact lenses at least 2 weeks before the examination
* Refractive errors: subjective hyperopia up to +6D, subjective astigmatism up to 5D, spherical equivalent (SEQ) up to +8D
* Best corrected visual acuity 0.8 (in US notation 20/25) or better on both eyes
* Participation in other ophthalmic studies
* Pregnant or nursing women, and women planning to become pregnant during the study
* Existing corneal implants
* Unstable refraction (over the last 2 years)
* Immunocompromised patients (e.g. AIDS or autoimmune diseases)
* Treatment with medications likely to affect wound healing such as steroids, antimetabolite or immunosuppressant
* Diagnosis of connective tissue disease or diabetes
* Any residual, recurrent or active disease of the eye (e.g. cataract; glaucoma suspect; corneal diseases; corneal thinning disorders such as keratoconus, pellucid marginal degeneration; dystrophy of basement membrane; exsudative macula degeneration; infections and inflammation of the eye) or of the cornea (e.g. corneal lesion or scarring; herpes simplex or herpes zoster keratitis)
* Defective position of eyelid
* Dry eye
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To proof the safety and efficacy of the new lenticule removal method for the refractive correction of hyperopia the following parameters will be measured 1, 3, 6, and 9 months post-op: <br>* uncorrected visual acuity (UCVA);<br>* manifest refraction (sphere and cylinder);<br>* best spectacle corrected visual acuity (BSCVA). <br>Additionally, there will be a patient questionery with respect to the subjective feeling of side effects and patient satisfaction (preoperativelly, 1, 3, 6, and 9 months post-op).
- Secondary Outcome Measures
Name Time Method