None listed
Conditions
Interventions
Intervention1: femtosecond laser system: NA
Control Intervention1: NIL: NIL
Sponsors
Mr. Samir Shah
New Vision Laser Centers (Rajkot) Pvt. Ltd. 203, Embassy Building, Jawahar Road, Opp. Jubilee Baug, Rajkot 360 001.Gujarat, India. Ph: (0281) 2240241, 2240239 Fax: (0281) 2240239
Eligibility
Inclusion criteria
Inclusion criteria: Older than 21 Central corneal thickness > 500 urn and calculated residual stroma thickness > 250 urn Normal cornea topography No prior refractive surgery The patients commit themselves to taking part in the post-surgery examinations planned for the clinical investigation. Patients who wear contact lenses should stop wearing their lenses 4 weeks before the preliminary examination in the case of hard lenses and 2 weeks before in the case of soft lenses. Patients should exhibit one of the following vision defects: a)Subjective hyperopia (SPH) of up to +8 D of natural cause, measured at the cornea level b)Subjective astigmatism (CYL) of up to 5 D, natural cause c)Spherocylindrical combinations of up to +8 D SEQ There are no restrictions regarding gender or race. The patients must sign a patient consent declaration which explains the conditions under which they take part in the clinical investigation, the alternative treatment types and the risks.
Exclusion criteria
Exclusion criteria: Patients who cannot lie flat and still for a short period Patients who are not capable of making themselves understood or giving their consent Known allergies or intolerances to medications administered Immunosuppressed patients, e.g. patients with AIDS or autoimmune disorders Treatment with medication which influence wound healing, e.g. steroids, antimetabolites and immunosuppressors Diagnosis of diabetes or connective tissue disorders Pregnant and breastfeeding women, plus women who are planning a pregnancy in the period of the clinical study Unstable refraction Any residual, recurrent, or acute ocular disease or abnormality of the eye to be treated. Cataract Suspected glaucoma or intraocular pressure >21mm Hg Disease of the cornea Disease involving thinning of the cornea such as keratoconus and pellucid marginal degeneration Dystrophy of basement membrane Exudative macular degeneration Infections and inflammations of the eye, e.g. uveitis, iritis, blepharitis Existing, recurrent, or acute ocular disease or abnormality of the eye to be treated. Existing corneal implant Lesion or scarring of the cornea Herpes simplex or herpes zoster keratitis Dry eyes Participation in other ophthalmic studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The change in refraction in the periods between 12 and 24 weeks and between 24 and 36 weeks after the surgery determined to assess the stability of the treatment. 2.The deviation from the target refraction per eye is used to determine the reproducibility of the procedure. At least 50% of the eyes should meet the target refraction within ± 0.5 D and 75% within 1 D. A variability of ± 0.25 D is within the limits of biological variability and the measurement accuracy of the procedure. Timepoint: 12 and 24 weeks and between 24 and 36 weeks.;Best Spectacle-Corrected Visual Acuity (BSCVA) or Uncorrected Visual Acuity (UCVA) is determined at the defined times by means of a standard vision test.Timepoint: after 24 and 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMr. Akash Bhavsar
Outcome results
None listed