- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07807761
Katarak Surgery and Care
Fear of Falling and Vision-Related Quality of Life of Patients Before and After Cataract Surgery, Evaluation of Postoperative Care Compliance: A Prospective Longitudinal Study
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: GÜLCAN Dürüst DÜRÜST SAKALLI
- Telefonnummer: 05428789621
- E-post: gulcan.durust@emu.edu.tr
Studer Kontakt Backup
- Navn: Gülten Sucu Dağ, Prof.
- E-post: gulten.sucu@emu.edu.tr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria Adults aged 18 years or older. Patients scheduled for cataract surgery. Able to communicate in Turkish and complete the questionnaires. Willing to participate voluntarily and provide informed consent. Willing to attend postoperative follow-up assessments at 1 and 3 months. Exclusion Criteria Presence of other ocular diseases that significantly affect visual function (e.g., advanced glaucoma, macular degeneration, or severe retinal disease).
Cognitive or communication problems that prevent completion of the questionnaires.
Development of a serious postoperative complication. Failure to complete the scheduled follow-up assessments.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Cataract Surgery Group
Description: A single cohort of patients undergoing cataract surgery will be followed prospectively from the preoperative period to 1 and 3 months after surgery. No research intervention will be administered. Participants undergoing cataract surgery will be followed prospectively from the preoperative period to 1 and 3 months after surgery. Fear of falling, vision-related quality of life, and postoperative care adherence will be assessed at the predefined follow-up time points. No additional intervention will be administered by the researchers. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Outcome Measure: Change in Vision-Related Quality of Life
Tidsramme: Baseline (preoperative) to 3 months after cataract surgery
|
Change in vision-related quality of life from the preoperative assessment to 3 months after cataract surgery, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25).
Higher scores indicate better vision-related quality of life.
|
Baseline (preoperative) to 3 months after cataract surgery
|
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Primary Outcome Measure: Vision-related quality of life measured by the NEI-VFQ-25
Tidsramme: Baseline (preoperative), 1 month, and 3 months after cataract surgery
|
Change in vision-related quality of life from the preoperative assessment to 1 month and 3 months after cataract surgery, measured using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25).
|
Baseline (preoperative), 1 month, and 3 months after cataract surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Outcome Measure: Fear of falling measured by the Falls Efficacy Scale-International (FES-I)
Tidsramme: Time Frame: Baseline (preoperative) and 3 months after cataract surgery
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Fear of falling will be assessed before and 3 months after cataract surgery.
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Time Frame: Baseline (preoperative) and 3 months after cataract surgery
|
|
Outcome Measure: Postoperative care adherence measured by the researcher-developed Cataract Surgery Postoperative Care Adherence Form
Tidsramme: Time Frame: 1 month and 3 months after cataract surgery
|
Postoperative adherence to recommended eye care and follow-up practices will be assessed at 1 and 3 months after cataract surgery.
|
Time Frame: 1 month and 3 months after cataract surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Dilber Keskinel, Dr., Bağsız
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Tan Y, Liu L, Li J, Qin Y, Sun A, Wu M. Effect of cataract surgery on vision-related quality of life among cataract patients with high myopia: a prospective, case-control observational study. Eye (Lond). 2022 Aug;36(8):1583-1589. doi: 10.1038/s41433-021-01697-6. Epub 2021 Jul 21.
- Wan Y, Zhao L, Huang C, Xu Y, Sun M, Yang Y, An L, Lv S, Yu Y, Chen D, Zhou P, Wang Y, Zhang M, Jiang A, Chen Z, Li X. Validation and comparison of the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) and the Visual Function Index-14 (VF-14) in patients with cataracts: a multicentre study. Acta Ophthalmol. 2021 Jun;99(4):e480-e488. doi: 10.1111/aos.14606. Epub 2020 Sep 17.
- Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Berry S, Hays RD; National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol. 2001 Jul;119(7):1050-8. doi: 10.1001/archopht.119.7.1050.
- Makabe K, Oshika T, Inamura M, Hayashi K, Sugita G, Kozawa T, Fujishima K. Influence of cataract surgery for the first or second eye on vision-related quality of life (VR-QOL) and the predictive factors of VR-QOL improvement. Jpn J Ophthalmol. 2020 Sep;64(5):468-477. doi: 10.1007/s10384-020-00762-z. Epub 2020 Aug 2.
- Groessl EJ, Liu L, Sklar M, Tally SR, Kaplan RM, Ganiats TG. Measuring the impact of cataract surgery on generic and vision-specific quality of life. Qual Life Res. 2013 Aug;22(6):1405-14. doi: 10.1007/s11136-012-0270-z. Epub 2012 Sep 27.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DoğuMU-SBF-HB-GDS-04
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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