VRQOL in Cataract Patients During the COVID-19 Pandemic

Sponsor

Medical University Innsbruck (Other)

Overall Status

Unknown status

CT.gov ID

NCT04468308

Collaborator

(none)

116

Enrollment

Location

5.7

Anticipated Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Senile Cataract	Other: Questionnaire

Study Design

Study Type:

Observational

Anticipated Enrollment :

116 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 8, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Improvement Vision-related quality of life [3 months]
Extent of improvement of vision-related qualitiy of life due to cataract surgery measured with the National Eye Institut Visual Function Questionnaire 25.

Secondary Outcome Measures

Delay of Vision-related quality of life [3 months]
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
Visual acuity [1 month]
Visual acuity difference between visual acuity at the time of indication for cataract surgery, on the day of surgery and one month postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University Innsbruck	Innsbruck	Tyrol	Austria	6020

Sponsors and Collaborators

Medical University Innsbruck

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University Innsbruck

ClinicalTrials.gov Identifier:

NCT04468308

Other Study ID Numbers:

VRQOL Cataract COVID-19

First Posted:

Jul 13, 2020

Last Update Posted:

Sep 23, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Cataract

Study Results

No Results Posted as of Sep 23, 2020