NCT04468308

Brief Summary

The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 22, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

September 23, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

June 22, 2020

Last Update Submit

September 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement Vision-related quality of life

    Extent of improvement of vision-related qualitiy of life due to cataract surgery measured with the National Eye Institut Visual Function Questionnaire 25.

    3 months

Secondary Outcomes (2)

  • Delay of Vision-related quality of life

    3 months

  • Visual acuity

    1 month

Study Arms (1)

Senile Cataract

Patient with senile cataract, whose cataract surgery was postponed in the COVID-19 pandemic

Other: Questionnaire

Interventions

Patients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively.

Senile Cataract

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with senile cataract with indication for for unilateral or bilateral cataract surgery.

You may qualify if:

  • Age ≥ 50 years
  • Senile cataract
  • Indication for unilateral or bilateral cataract surgery
  • Postponed cataract surgery due to the COVID-19 pandemic
  • Signed and dated declaration of consent

You may not qualify if:

  • Complex form of cataract (traumatic cataract, secondary cataract after intraocular inflammation)
  • Amblyopia on the eye that is to be operated on
  • Severe, visually impairing eye disease on the eye that is to operated on
  • Known dementia or memory problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 13, 2020

Study Start

September 8, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations