Computer-based Tutorial as a Means to Enhance the Informed Consent Process for Cataract Surgery

NCT07167576 | Completed

• 1 other identifier: CAT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Informing the patient and obtaining the informed consent is one of the major duties physicians perform before beginning a medical treatment. Some years ago we developed the so-called CatInfo programme that allows to inform the patient inter-actively prior to the face-to-face interview with the physician. This program was found to lead to significantly better informed patients in our hospital. Although these findings were significant, we would like to investigate more on two other aspects in this study: Firstly, we would like to learn more about the patients' attitude before and after surgery. Therefore, we would like to ask the patients' about their willingness of being informed and decision making using a standardised questionnaire. Secondly, we would like to investigate on the differences in the duration of informed consent taking in patients that have heard and seen the CatInfo vs. patients received no information prior to the face-to-face interview with the physician. Patients will be randomly assigned to one of these groups. This difference will then be evaluated together with the result of the MCQ (assessing the patients' knowledge concerning cataract surgery after informed consent taking). The primary hypothesis is that patients' are better informed after watching the CatInfo tool although the face-to face interview is shorter.

Conditions

Patients' Information Level About Cataract Surgery; Patients' Attitude Before and After Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• patients' attitude before and after cataract surgery

  assessed by validated questionnaires

  one month

Secondary Outcomes (1)

• - Difference concerning duration of the face to face interview with the physician between both groups

  one hour

Study Arms (2)

Catinfo and discussion group

ACTIVE COMPARATOR

Patients watch a short computer presentation on the Catinfo tool before the discussion with the physician

Other: Catinfo tool and discussion with physician

Discussion group

ACTIVE COMPARATOR

Patients have the standard discussion with the physician

Other: discussion with physician

Interventions

Catinfo tool and discussion with physician OTHER

Patients in the study group watch a computer presentation with information about the cataract surgery

Catinfo and discussion group

discussion with physician OTHER

Patients in the control group have a discussion with the physician

Discussion group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract
• Age 18 and older
• First eye to be operated
• No previous ophthalmic surgery
• written informed consent to participation in the study

You may not qualify if:

• Visual acuity of less than 0.1 Snellen in the worse eye
• Severe hearing loss
• Inability to use touch screen device (e.g. severe tremor, etc.)

Sponsors & Collaborators

• Vienna Institute for Research in Ocular Surgery: lead

Study Sites (1)

Vienna Institute for Research in Ocular Surgery

Vienna, Vienna, 1140, Austria

Location

MeSH Terms

Interventions

Physicians

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Oliver Findl, MD

  Vienna Institute for Research in Ocular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 11, 2025

Record last verified: 2010-09

Locations

AU (1)