VRQOL in Cataract Patients During the COVID-19 Pandemic

Assessment of Vision-related Quality of Life (VRQOL) in Cataract Patients During the COVID-19 Pandemic

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.

Study Overview

• Status: Unknown
• Conditions: Senile Cataract
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Anticipated): 116

Contacts and Locations

• Study Contact: Name: Teresa Rauchegger, Dr.; Phone Number: +43 512 504 23721; Email: teresa.rauchegger@i-med.ac.at
• Study Contact Backup: Name: Claus Zehetner, Dr.; Phone Number: +43 512 504 23721; Email: claus.zehetner@i-med.ac.at

Study Locations

• Austria
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
      • Contact: Teresa Rauchegger, Dr.; Phone Number: +43 512 504 24184; Email: teresa.rauchegger@i-med.ac.at
      • Contact: Claus Zehetner, Dr.; Phone Number: +43 512 504 24184; Email: claus.zehetner@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Senile Cataract; Patient with senile cataract, whose cataract surgery was postponed in the COVID-19 pandemic	Other: Questionnaire; Patients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay of Vision-related quality of life	Delay of improvement of vision-related qualitiy of life in the COVID-19 pandemic measured in days between the originally scheduled operation and the actual operation date	3 months
Visual acuity	Visual acuity difference between visual acuity at the time of indication for cataract surgery, on the day of surgery and one month postoperatively.	1 month

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Eye Diseases; Lens Diseases; COVID-19; Cataract
• Other Study ID Numbers: VRQOL Cataract COVID-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No