NCT05215002

Brief Summary

To analyse quality assurance after cataract surgery by assessing discomfort and other symptoms via telephone interviews either in the evening of the day of the surgery or 1 day after surgery versus no additional call after surgery.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 19, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

February 14, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

January 18, 2022

Last Update Submit

January 29, 2022

Conditions

Cataract

Keywords

Telephone Call

Outcome Measures

Primary Outcomes (1)

  • Number of patients

    The number of patients in group 1 and group 2 seen at the outpatient clinic between surgery of the first and the second eye will be documented

    24 months

Secondary Outcomes (2)

  • Patient's Satisfaction

    24 months

  • Patient's Symptoms

    24 months

Study Arms (2)

Telephone call

EXPERIMENTAL

Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery

Other: Telephone Call

No telephone call

EXPERIMENTAL

Patient will not receive a telephone call in the evening of the day of the surgery or one day after surgery

Other: No telephone call

Interventions

Telephone CallOTHER

Patient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints

Telephone call
No telephone callOTHER

Patient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints

No telephone call

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women aged 18 and older
  • planned cataract surgery of both eyes
  • good knowledge of the german language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital

Vienna, 1140, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Oliver Findl, MD

    Vienna Institute for Research in Ocular Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Findl, MD

CONTACT

+43 (1) 91021office@viros.at

Manuel Ruiss, MD

CONTACT

+43 (1) 91021office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 31, 2022

Study Start

November 19, 2019

Primary Completion

November 1, 2022

Study Completion

November 1, 2023

Last Updated

February 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)