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Laser Correction of Astigmatism Using Vector Analysis

30. mai 2021 oppdatert av: Esraa Fathy Rateb Hassan, Assiut University

Adjustment of Astigmatism for Laser Correction Using Vector Planning Calculator

To determine the effectiveness of correcting astigmatism by laser refractive surgery by a vectorial astigmatism outcome analysis that uses 3 fundamental vectors : target induced astigmatism vector ( TIA) , surgically induced astigmatism vector , and difference vector , as described by Alpins method.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

Astigmatism is a condition of the eye where the cornea (clear window in front of the eye) has 2 different curvatures (much like an American football cut in half) so that, instead of being a single focal point, there ends up being two different focal points, neither of which is in focus.

As you can imagine, this makes whatever you are looking at blurred and fuzzy like a camera out of focus. Both objects up close and far away can look blurred and fuzzy with astigmatism. Many people with astigmatism also are nearsighted or farsighted.

There are several different treatment options if you have astigmatism with or without nearsightedness or farsightedness. Various treatment options available from an eye specialist include: Glasses, Contact Lenses and Laser Eye Surgery

Laser Eye Surgery:

Laser eye surgery, or laser vision correction, involves using lasers to reshape the front surface (cornea) of your eyes so that you can focus better. It can correct short-sightedness , long-sightedness and astigmatism.There are several different laser eye surgery options that can be used to help correct vision problems caused by astigmatism.Laser eye surgery corrects the refractive error in the cornea so that, instead of there being two focal points, there will be only one focal point that is in focus post-surgery.Laser vision correction can be used if you have astigmatism with or without nearsightedness or farsightedness.However, what laser eye procedures you are an ideal candidate for will vary based on your vision correction needs LASIK( Laser ASsisted In-situ Keratomileusis ),PRK ( Photorefractive Keratectomy ) and SMILE (Small Incision Lenticule Extraction ) . Unlike glasses or contacts, which just address astigmatism so you can see clearly with assistive devices, laser eye surgery is the only treatment to potentially resolve astigmatism so you no longer need glasses or contacts. To determine the effectiveness of correcting astigmatism by laser refractive surgery by a vectorial astigmatism outcome analysis that uses 3 fundamental vectors: target induced astigmatism vector (TIAT), surgically induced astigmatism vector, and difference vector, as described by the Alpins method.

Alpins method :

This method of astigmatism analysis enables the examination of results of astigmatism treatment by both refractive and corneal measurements. The approach uses vector analysis, which is used in this series for examining regular astigmatism. This can be further applied to irregular astigmatism by separately examining the 2 halves of the cornea by adding a second analysis between 181and 360 degrees and displaying both together on a 360 degree polar diagram as they would appear on an eye or topography map drawn between the two points . The length of this line represents the WTW ( White To White ) value [16].

Studietype

Observasjonsmessig

Registrering (Forventet)

50

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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 til 40 år (Voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Study will include 50 patients in different ages .

Beskrivelse

Inclusion Criteria:

  • At least 18 years of age .
  • Stable eyeglass and contact lenses prescription for at least 2 to 3 years .
  • Stable vision over at least the past year .
  • No history or findings of active corneal disease .
  • No significant dry eye .
  • Not pregnancy or nursing .
  • Refractive cylinder more than -1D (Diopter) .

Exclusion Criteria:

Certain conditions make the method inadvisable :

  • Residual , recurrent or active ocular disease such as uveitis , sever dry eyes , sever allergic eye disease , glaucoma visually significant cataract , and retinal disease .
  • Previous corneal surgery or trauma within the corneal flap zone .
  • Patent corneal vascularisation within 1mm of the corneal flap zone .
  • Age less than 18 years old .
  • Pregnancy or breast feeding .
  • Certain medical conditions such as autoimmune diseases (eg. lupus , rheumatoid arthritis), immunodeficiency states (eg. HIV) and diabetes may prevent proper healing after a refractive procedure.
  • Systemic medications likely to affect wound healing such as retinoic acid and steroids .
  • Keratoconus or other active eye disease .

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
. Post operative Visual Acuity
Tidsramme: one year

To determine the effectiveness of correcting astigmatism by laser refractive surgery by a vectorial astigmatism outcome analysis by : CDVA and UCDVA, pentacam , 3 month, 6 month and 1 year after surgery.

  • 3 months postoperative : assessment of visual acuity using corrected distance visual acuity (CDVA) , and uncorrected distance visual acuity (UCDVA) and pentacam measures .
  • 6 months postoperative : assessment of visual acuity using corrected distance visual acuity (CDVA) , and uncorrected distance visual acuity (UCDVA) and pentacam measures .
  • One year postoperative : assessment of visual acuity using corrected distance visual acuity (CDVA) , and uncorrected distance visual acuity (UCDVA) and pentacam measures .
one year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative Assessment
Tidsramme: 3 months
Wavefront Analysis of post operative corneal results , 3 months after surgery to assess visual acuity . wavefront analysis is that it measures the entire visual system, rather than just the corneal surface, as in corneal topography.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Abdelnasser Awad, Professor, Ophthalmology department
  • Hovedetterforsker: Khaled Abdelazeem, Asst. Prof, Ophthalmology department
  • Hovedetterforsker: Mohamed Anwer, Lecturer, Ophthalmology department

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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 (Forventet)

1. juli 2021

Primær fullføring (Forventet)

1. juli 2022

Studiet fullført (Forventet)

1. august 2022

Datoer for studieregistrering

Først innsendt

25. mai 2021

Først innsendt som oppfylte QC-kriteriene

30. mai 2021

Først lagt ut (Faktiske)

4. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2021

Sist bekreftet

1. mai 2021

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Adjustment of Astigmatism

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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