- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00691431
IntraLase vs Hansatome Flaps in LASIK
Comparison of the IntraLaser Femtosecond Laser and Hansatome Mechanical Keratome for Laser In Situ Keratomileusis
Studieoversigt
Undersøgelsestype
Tilmelding
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University School of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Inclusion criteria were "T 6.00 D of spherical myopia, "T 3.00 D of refractive astigmatism, stable refraction (less than 0.50D per year of sphere or cylinder), corneal diameter less than 11.0 mm to allow for suction fixation ring, soft contact wearer with discontinuation of wear at least 7 days prior to preoperative evaluation, visual acuity correctable to at least 20/20 in both eyes, more than 21 years of age, ability to participate in follow-up examinations for 12 months after LASIK surgery. In order to fairly compare the visual outcomes of the two keratomes, patients were required to have closely matched eyes, in terms of refractive error. Exclusion Criteria:Exclusion criteria include rigid gas permeable contact lens wearer, severe dry eyes, severe blepharitis, anterior segment pathology (cataracts or corneal scarring or neovascularization within 1 mm of intended ablation zone), recurrent corneal erosion, severe basement membrane disease, progressive or unstable myopia or keratoconus, unstable corneal mires on central keratometry, corneal thickness in which LASIK procedure would result in less than 250 micros or remaining posterior corneal thickness below the flap postoperatively, baseline standard manifest refraction > 0.75 D more minus in sphere power, or a difference of greater than 0.50D in cylinder power compared to baseline standard cycloplegic refraction, two eyes for which the baseline standard cycloplegic refraction differ from each other more than 0.75 in sphere, 0.50 D in cylinder, or have a different type of astigmatism (i.e. with-the-rule) when the cylinder is > 0.50D, or preoperative assessment of ocular topography and/or aberrations indicates that either eye is not suitable candidate for LASIK vision correction procedure (ie forme fruste keratoconus, corneal warpage, or pellucid marginal degeneration), previous intraocular or corneal surgery, and history of herpes zoster or simplex keratitis, patients on systemic corticosteroid or immunosuppressive therapy, immunocompromised subjects or clinically significant atopic disease, connective tissue disease, or diabetes, steroid responder, macular pathology, pregnant or lactating patients, patients with sensitivity to planned study concomitant medications or patients participating in another ophthalmic drug or device clinical trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Synsstyrke
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Sekundære resultatmål
Resultatmål |
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Kontrastfølsomhed
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SU-05302008-1190
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-
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Stanford UniversityAktiv, ikke rekrutterende
-
Assiut UniversityUkendt
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University of MichiganTrukket tilbage
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Instituto de Olhos de GoianiaAfsluttetAnisometropiBrasilien
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Innovative MedicalAfsluttet
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Bismarck LasikSengiAfsluttet
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University of UtahAfsluttet