- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02519673
Comparison of Corneal Stromal Tissue Consumption (LATAC) (LATAC)
Comparison of Corneal Stromal Tissue Consumption Values Estimated When Programming the Intervention Versus the Values Measured by Pre and Postoperative Topography
In refractive surgery, stromal ablation depth is fundamental because it determines the thickness of the residual posterior wall. The posterior wall is an essential element that guarantees the refractive stability and the long term prevention of corneal ectasia after corneal refractive surgery. A minimum thickness of more or less 300 microns is universally accepted. Its calculation is based on well-known formulas, such as Munnerlynn ones.
With the excimer laser platform last generation WaveLight® Allegretto® EX-500 of Alcon, a new treatment option called "wavefront optimized" is offered for myopia, astigmatism and hyperopia. The ablation profile has been developed to save stromal tissue consumption and to favor the quality of vision, by optimizing connections between the optical zone and the transition zone of the photoablation. Alongside the theoretical formulas, evaluation of the depth of ablation may be defined by differential ultrasonic pachymetry or by topographical analysis pre and postoperatively. The latter is currently the method of reference to assess the corneal thickness.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Paris, Frankrig, 75019
- Fondation ophtalmique Adolphe de Rothschild
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients having a refractive disorder and for whom a refractive surgery is programmed.
Exclusion Criteria:
- Patient opposed to participation in the study
- Another refractive surgery technique
- Hyperopic patient
- Pregnant or lactating woman
- Patient under a measure of legal protection
- Absence of affiliation to social security or universal health coverage (CMU)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Difference between stromal tissue consumption, expressed in micrometers, estimated before surgery by WaveLight Allegretto EX-500 laser and measured one month after surgery by Pentacam
Tidsramme: One month
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Stromal tissue consumption will be estimated preoperatively by WaveLight Allegretto EX-500 laser and central corneal thickness will be measured by Pentacam.
One month after refractive surgery, during follow-up,central corneal thickness will be again measured by Pentacam.
The difference between the estimated and the measured tissue consumption will be calculated.
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One month
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JFO_2015_26
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Kliniske forsøg med Measurement of stromal tissue ablation
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University of Colorado, DenverNational Cancer Institute (NCI)RekrutteringBørnekræft | OverlevelseForenede Stater
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Profound Medical Inc.AfsluttetProstatakræftForenede Stater, Canada, Tyskland
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Samuel Lunenfeld Research Institute, Mount Sinai...Ikke rekrutterer endnuVelvære, psykologiskCanada
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Galvanize Therapeutics, Inc.Aktiv, ikke rekrutterende
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National Institute of Allergy and Infectious Diseases...PPDAktiv, ikke rekrutterende