- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01893671
Corneal Power, Astigmatism, and Aberration Changes After LASIK
4. april 2018 oppdatert av: David Huang, Oregon Health and Science University
Observational Study of Corneal Power, Astigmatism, and Aberration Changes After LASIK
The primary goal of the study is to determine if Optical Coherence Tomography (OCT) measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography.
A second goal is to evaluate OCT-based epithelial thickness mapping.
The postoperative epithelial thickness variation will be used to calculate refractive effects and calibrate the smoothing parameter in the mathematical model relating corneal mean curvature and epithelial thickness.
A third goal is to assess the repeatability of OCT measurements.
A fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
A prospective observational study on refraction and HOA changes after LASIK will be conducted at OHSU and Baylor.
We will enroll 50 subjects undergoing routine LASIK for the correction of myopia or hyperopia.
The Optovue anterior segment OCT prototype will be used to measure corneal power, astigmatism, HOA, and epithelial thickness map.
The ultrahigh-speed MIT OCT prototypes will also be used when they become available.
A comprehensive eye examination will be performed preoperatively.
OCT scan, manifest refraction, visual acuity, Placido-ring corneal topography, slit scanning/Scheimpflug camera, and wavefront measurements will be acquired preoperatively and 3-6 months after the surgery.
The LASIK-induced refraction and wavefront HOA changes will be used as the reference standard to evaluate the accuracy of OCT-measured corneal power, astigmatism, and HOA changes.
The primary goal of the study is to determine if OCT measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography.
A second goal is to evaluate OCT-based epithelial thickness mapping.
The postoperative epithelial thickness variation will be used to calculate refractive effects and calibrate the smoothing parameter in the mathematical model relating corneal mean curvature and epithelial thickness.
A third goal is to assess the repeatability of OCT measurements.
A fourth goal is to develop a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype.
The reference standard for lens focusing power and astigmatism will be based on a Gaussian optics model that takes as inputs manifest refraction, crystalline lens position, axial eye length, and OCT corneal power and astigmatism measurements.
The reference standard for lens HOA will be the difference between wavefront HOA and corneal HOA.
For each eye, the best-fit effective index of the lens will be found so that OCT measurements will match the reference data.
Although the lens index is likely to be higher centrally than peripherally, this secondary perturbation will be accounted for by a posterior shift of the posterior lens capsule in OCT images, due to the fact that apparent distances in OCT images is a product of physical distance and optical group index.
Thus HOA due to index variation in the lens would translate to unevenness in the posterior capsule surface that could be measured with OCT.
Studietype
Observasjonsmessig
Registrering (Faktiske)
22
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health & Science University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Subjects undergoing routine LASIK for the correction of myopia or hyperopia with or without astigmatism
Beskrivelse
Inclusion Criteria:
1. Patients who qualify for primary LASIK for either myopia or hyperopia, with or without astigmatism.
Exclusion Criteria:
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Bare etui
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
LASIK
Subjects undergoing routine LASIK for the correction of myopia or hyperopia.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
OCT measurement of corneal power and astigmatism vs Placido-ring
Tidsramme: 5 year
|
primary goal of the study is to determine if OCT measurement of corneal power and astigmatism is more accurate than conventional Placido-ring corneal topography
|
5 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
An evaluation of OCT-based epithelial thickness mapping
Tidsramme: 5 year
|
The postoperative epithelial thickness variation will be used to calculate refractive effects and calibrate the smoothing parameter in the mathematical model relating corneal mean curvature and epithelial thickness.
|
5 year
|
|
OCT measurements repeatability
Tidsramme: 5 year
|
An assessment of the repeatability of OCT measurements
|
5 year
|
|
The Development of a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens
Tidsramme: 5 year
|
The Development of a method of estimating the focusing power, astigmatism, and HOA of the crystalline lens based on measurements of the lens' anterior and posterior capsular topographies and positions with the ultrahigh-speed MIT OCT prototype.
|
5 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: David Huang, MD, PhD, Oregon Health & Science Universtiy
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
31. august 2017
Studiet fullført (Faktiske)
31. august 2017
Datoer for studieregistrering
Først innsendt
2. juli 2013
Først innsendt som oppfylte QC-kriteriene
2. juli 2013
Først lagt ut (Anslag)
9. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OHSU IRB#6612
- R01EY018184 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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