- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: GÜLCAN Dürüst DÜRÜST SAKALLI
- Telefonnummer: 05428789621
- E-post: gulcan.durust@emu.edu.tr
Studera Kontakt Backup
- Namn: Gülten Sucu Dağ, Prof.
- E-post: gulten.sucu@emu.edu.tr
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Outcome Measure: Change in Vision-Related Quality of Life
Tidsram: 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
|
|
Primary Outcome Measure: Vision-related quality of life measured by the NEI-VFQ-25
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Outcome Measure: Fear of falling measured by the Falls Efficacy Scale-International (FES-I)
Tidsram: Time Frame: Baseline (preoperative) and 3 months after cataract surgery
|
Fear of falling will be assessed before and 3 months after cataract surgery.
|
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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Dilber Keskinel, Dr., Bağsız
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- DoğuMU-SBF-HB-GDS-04
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