CompletedNot Applicable

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

Austria90 participantsStarted 2010-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cataract * Age 18 and older * First eye to be operated * No previous ophthalmic surgery * written informed consent to participation in the study Exclusion Criteria: * 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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

patients' attitude before and after cataract surgery

Timeframe: one month

Trial details

NCT IDNCT07167576

SponsorVienna Institute for Research in Ocular Surgery

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

View on ClinicalTrials.gov More Patients' Information Level About Cataract Surgery trials