NCT07807761

Brief Summary

Although cataract surgery is an effective treatment method for improving visual function, it is important to evaluate the quality of life, daily living activities, independence level and psychosocial well-being of patients in the postoperative period. Changes in visual function can affect individuals' ability to live their daily lives, their perception of the risk of falling, and their adaptation to post-treatment care processes. For this reason, the recovery process after cataract surgery should be evaluated not only with clinical results, but also with patient-centered outcome criteria. The aim of this research is to investigate the preoperative and postoperative period in patients undergoing cataract surgery 1. and 3. The aim is to prospectively evaluate changes in care compliance, fear of falling, and vision-related quality of life during monthly follow-ups.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

September 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

September 21, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

September 8, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

Cataract; Cataract Surgery; Fear of Falling; Vision-Related Quality of Life; NEI-VFQ-25; Postoperative Care; Care Adherence; Visual Function

Outcome Measures

Primary Outcomes (2)

  • Outcome Measure: Change in Vision-Related Quality of Life

    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

    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

Secondary Outcomes (2)

  • Outcome Measure: Fear of falling measured by the Falls Efficacy Scale-International (FES-I)

    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

    Time Frame: 1 month and 3 months after cataract surgery

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 years and older who are scheduled to undergo cataract surgery at Dr. Burhan Nalbantoğlu State Hospital, Nicosia, Northern Cyprus.

You may not qualify if:

  • Cognitive or communication problems that prevent completion of the questionnaires.
  • Development of a serious postoperative complication. Failure to complete the scheduled follow-up assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

Related Links

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Dilber Keskinel, Dr.

    Bağsız

    STUDY CHAIR

Central Study Contacts

GÜLCAN Dürüst DÜRÜST SAKALLI

CONTACT

Gülten Sucu Dağ, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecture Dr.

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 8, 2026

Study Start

September 21, 2026

Primary Completion

September 21, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

September 8, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Not applicable. Individual participant data (IPD) will not be shared with other researchers.