NCT03748368

Brief Summary

Investigate if a computer-based tutorial enhances the quality and efficiency of the informed consent process for cataract surgery in Turkish or Serbian speaking patients.

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
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

November 19, 2018

Last Update Submit

October 1, 2019

Conditions

Cataract

Keywords

Cataract surgeryInformed Consent Process

Outcome Measures

Primary Outcomes (1)

  • Number of correctly answered questions between study group and control group

    Patients are asked to complete a multiple choice questionnaire concerning cataract surgery. Correctly answered questions will be summated. The scale ranges from a minimum of 0 points to a maximum of 19 points. The more points the better the patients knowledge about cataract

    12 months

Secondary Outcomes (1)

  • Usability of the touchscreen device

    12 months

Study Arms (2)

Cataract presentation

ACTIVE COMPARATOR

Cataract presentation prior to surgery

Other: Cataract presentation

Placebo presentation

PLACEBO COMPARATOR

Placebo presentation prior to surgery

Other: Placebo presentation

Interventions

Cataract presentationOTHER

Presentation about cataract surgery

Cataract presentation
Placebo presentationOTHER

Presentation about the history of the hospital

Placebo presentation

Eligibility Criteria

Age21 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract
  • Age 21 and older
  • First eye to be operated
  • No previous ophthalmic surgery
  • Written informed consent to participation in the study

You may not qualify if:

  • Not literate in Serbian (Serbian group) / Turkish (Turkish group) or German (both groups)
  • Visual acuity of less than 6/60 in the worse eye
  • Severe hearing loss
  • Inability to use touch screen device (e.g. severe tremor, etc.)
  • Pregnancy - for women in the reproductive age a pregnancy test is required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna Institute for Research in Ocular Surgery (VIROS)

Vienna, 1149, Austria

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Central Study Contacts

Nino Hirnschall, MD

CONTACT

01 91021-57564office@viros.at

Manuel Ruiß, MSc.

CONTACT

01 91021-57564office@viros.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 20, 2018

Study Start

January 1, 2017

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

October 2, 2019

Record last verified: 2019-10

Locations

AU(1)