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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00769808
Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism.
24 de agosto de 2020 actualizado por: Bausch & Lomb Incorporated
A Prospective Trial to Evaluate the Safety and Effectiveness of the Bausch & Lomb Technolas® 217z Laser With Zyoptix® Aspheric Algorithm When Used for the LASIK Treatment of Myopia and Myopic Astigmatism
The purpose of this study is to evaluate the safety and effectiveness of the Bausch & Lomb Technolas 217z laser with the investigational Zyoptix Aspheric Algorithm when used for LASIK treatment of myopia and myopic astigmatism.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
72
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5X1C8
- Lasik MD, 130 King Street
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Subjects who were of legal age (at least 18) and had full legal capacity to volunteer.
- Subjects must be willing to have both eyes treated with the laser.
- Subjects must have up to -12.00D of absolute spherical myopia (not spherical equivalent) with up to -6.00D of refractive astigmatism, with a spherical equivalent up to -15.00D as measured by manifest subjective refraction.
- Subjects who had less than 0.75 D of difference in the preoperative manifest spherical equivalent and cycloplegic spherical equivalent subjective refractions.
(Manifest subjective refractions adjusted for optical infinity were used.)
- High contrast, manifest best spectacle-corrected distance logMAR visual acuity correctable to at least 0.3 in both eyes, and must not differ between eyes by more than 1 line (5 letters).
- Contact lens wearers must have 2 Orbscan measurements and 2 manifest subjective refractions taken preoperatively at least 1 week apart.
- Contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 2 weeks prior to the preoperative evaluation.
Exclusion
- Subjects with uncorrected visual acuity better than 20/40 (Snellen) or 0.3 logMAR
- Subjects who were immuno-compromised or had a diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that increased the risk to the subject or could have confounded the outcomes of this study.
- Subjects with uncontrolled glaucoma or glaucoma who were under treatment in the study eye or with ocular hypertension.
- Subjects who demonstrated evidence of retinal vascular disease.
- Subjects who have an ocular muscle disorder including strabismus or nystagmus, or other disorders that affected fixation.
- Subjects who were at risk for angle closure or who had a potentially occludable angle, as evidenced by a shallow anterior chamber on slit lamp exam, confirmed by gonioscopy as deemed necessary by the study Investigator.
- Subjects who had undergone previous intraocular or corneal surgery of any kind, including any type of excimer laser surgery for either refractive or therapeutic purposes.
- Subjects who were taking systemic medications likely to affect wound healing such as corticosteroids or anti-metabolites or any other medications that may increase the risk to the subject or confound the outcomes of this study.
- Subjects for whom the combination of their preoperative corneal thickness and the planned operative parameters for the LASIK procedure could have resulted in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Technolas 217z Excimer Laser
Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.
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LASIK correction of myopia and myopic astigmatism
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
Periodo de tiempo: 3 months
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3 months
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Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia
Periodo de tiempo: 3 months
|
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis.
Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina.
Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder.
It is expressed in diopters (D).
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3 months
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Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity
Periodo de tiempo: Baseline, 3 months
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Mean change in best-corrected high contrast distance visual acuity.
Corrected means spectacle corrected.
Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity.
The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters.
The total number of correct letters were recorded.
A decrease in the number of correct letters indicates a decrease in visual acuity.
Acuity was averaged across visits.
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Baseline, 3 months
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Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
Periodo de tiempo: 3 months
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3 months
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Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder
Periodo de tiempo: 3 months
|
Manifest refractions (eyeglass prescriptions) have three components: sphere, cylinder, and axis.
Sphere and cylinder are both expressed in diopters, which is a continuous measure of the focusing power needed to make the image sharp on the retina.
Manifest refraction spherical equivalent (MRSE) is equal to sphere + ½ x cylinder.
It is expressed in diopters (D).
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3 months
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Percentage of Eyes That Had High Contrast Best Spectacle Corrected Visual Acuity (HCBSCVA) of 20/20 or Better at Baseline Had a Visual Outcome Worse Than 20/40 at 3 Months
Periodo de tiempo: 3 months
|
Corrected means spectacle corrected.
Visual acuity (VA) was reported as letters read correctly, and the letters read were converted to logarithm of the minimum angle of resolution (logMAR) acuity.
The participant read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters.
The total number of correct letters were recorded.
A decrease in the number of correct letters indicates a decrease in visual acuity.
Acuity was averaged across visits.
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3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percentage Change From Baseline in Higher Order Aberrations.
Periodo de tiempo: Baseline, 3 months
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The aberrations in the eye's optical system were measured over the entire pupil by the Bausch & Lomb Zywave II WaveFront Aberrometer, a Hartmann-Shack type device.
The pupil should have been at least 6 mm in diameter using 2.5% phenylephrine as a dilating agent to maximize the pupil diameter and hence the amount of wavefront information collected by the Zywave II.
The wavefront data was then fitted with Zernike polynomials representing the 2nd, 3rd, 4th and 5th order Zernike terms.
These terms represent the wavefront aberration of the eye.
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Baseline, 3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mark Cohen, MD, Lasik MD
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de agosto de 2008
Finalización primaria (Actual)
1 de marzo de 2010
Finalización del estudio (Actual)
1 de marzo de 2010
Fechas de registro del estudio
Enviado por primera vez
8 de octubre de 2008
Primero enviado que cumplió con los criterios de control de calidad
8 de octubre de 2008
Publicado por primera vez (Estimar)
9 de octubre de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2020
Última verificación
1 de agosto de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 564
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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