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Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome

23. juli 2026 opdateret af: Kata Culina

Influence of Corneal Biomechanics on Surgically Induced Astigmatism After Cataract Surgery in Patients With Pseudoexfoliation Syndrome

This prospective study aims to evaluate the influence of corneal biomechanical properties on surgically induced astigmatism following standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with patients without pseudoexfoliation. Corneal hysteresis (CH), corneal resistance factor (CRF) and corneal astigmatism will be measured before surgery and at postoperative follow-up visits. The relationship between changes in corneal biomechanics and surgically induced astigmatism will be analyzed.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Pseudoexfoliation syndrome is associated with structural alterations of the anterior segment and may affect the biomechanical behavior of the cornea. Corneal hysteresis (CH) and corneal resistance factor (CRF), measured using the Ocular Response Analyzer, are indicators of corneal biomechanical properties and may influence the corneal response to cataract surgery and magnitude of surgically induced astigmatism.

This prospective, single-center observational study will include approximately 70 patients undergoing routine phacoemulsification cataract surgery. Participants will be allocated into two groups according to the presence or absence of pseudoexfoliation syndrome.

CH, CRF and corneal astigmatism will be measured preoperatively and postoperatively at scheduled follow-up visits at postoperative day 1, 7 and 30. Surgically induced astigmatism will be calculated from keratometric measurements.

The primary objective of the study is to determine whether correlations exist between corneal biomechanical properties (CH and CRF) and surgically induced astigmatism in patients with pseudoexfoliation syndrome and to compare these correlations with those observed in patients without pseudoexfoliation syndrome.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

70

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kroatien
    • Splitsko-dalmatinska County
      • Split, Splitsko-dalmatinska County, Kroatien, 21000
        • Eye Clinic Medic Jukic
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Kata Culina, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population will consist of adult patients with age-related cataract scheduled for routine phacoemulsification cataract surgery at Eye clinic Medic Jukic. Participants will include patients with pseudoexfoliation syndrome and an a control group without pseudoexfoliation syndrome of similar age range. Consecutive eligible patients who meet the inclusion criteria and provide written informed consent will be enrolled.

Beskrivelse

Inclusion Criteria:

  • Adults aged 50-85 years
  • Age-related cataract scheduled for standard phacoemulsification cataract surgery with intraocular lens implantation
  • Presence of pseudoexfoliation syndrome (PEX group) or absence of pseudoexfoliation syndrome (control group)
  • Ability to provide written informed consent
  • Willingness to attend all scheduled postoperative follow-up visits

Exclusion Criteria:

  • Previous ocular surgery in the study eye
  • Corneal diseases or abnormalities that may affect corneal biomechanical measurements or keratometry
  • Glaucoma and ocular hypertension
  • Ocular trauma or active ocular inflammation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Pseudoexfoliation syndrome
Patients with pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery
Procedure: phacoemulsification cataract surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.
Control group
Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery
Procedure: phacoemulsification cataract surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between corneal biomechanical properties and surgically induced astigmatism
Tidsramme: Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.
To evaluate the correlation between corneal hysteresis (CH), corneal resistance factor (CRF), and surgically induced astigmatism (SIA) after phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome and compare the findings with a control group.
Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kata Culina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. oktober 2026

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AST-PEXCAT-2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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