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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00769808
Technolas 217z Laser With Zyoptix Aspheric Algorithm Used for the LASIK Treatment of Myopia and Myopic Astigmatism.
24 agosto 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
72
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Ontario
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Toronto, Ontario, Canada, M5X1C8
- Lasik MD, 130 King Street
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Technolas 217z Excimer Laser
Bausch & Lomb Zyoptix Aspheric Algorithm for LASIK correction of myopia and myopic astigmatism.
|
LASIK correction of myopia and myopic astigmatism
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Eyes With Uncorrected High Contrast Distance Visual Acuity of 20/40 or Better
Lasso di tempo: 3 months
|
3 months
|
|
|
Percentage of Eyes With Manifest Subjective Refraction (MRSE) Within ± 1.00 Diopter (D) and 0.50 D of Emmetropia
Lasso di tempo: 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).
|
3 months
|
|
Preservation of Manifest Best Corrected High Contrast Distance Visual Acuity
Lasso di tempo: Baseline, 3 months
|
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.
|
Baseline, 3 months
|
|
Percentage of Eyes With Manifest Best-corrected Distance Photopic Visual Acuity Decrease of 2 or More Lines
Lasso di tempo: 3 months
|
3 months
|
|
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Percentage of Eyes With > 2.00 Diopter of Induced Postoperative Refractive Cylinder
Lasso di tempo: 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).
|
3 months
|
|
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
Lasso di tempo: 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.
|
3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage Change From Baseline in Higher Order Aberrations.
Lasso di tempo: Baseline, 3 months
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Mark Cohen, MD, Lasik MD
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2008
Completamento primario (Effettivo)
1 marzo 2010
Completamento dello studio (Effettivo)
1 marzo 2010
Date di iscrizione allo studio
Primo inviato
8 ottobre 2008
Primo inviato che soddisfa i criteri di controllo qualità
8 ottobre 2008
Primo Inserito (Stima)
9 ottobre 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 agosto 2020
Ultimo verificato
1 agosto 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 564
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .