Patients' Information Level About Cataract SurgeryNCT07167576
Computer-based Tutorial as a Means to Enhance the Informed Consent Process for Cataract Surgery
A study testing Catinfo tool and discussion with physician and discussion with physician in people with Patients' Information Level About Cataract Surgery and Patients' Attitude Before and After Cataract Surgery, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients' Information Level About Cataract Surgery, Patients' Attitude Before and After Cataract Surgery
- What is being tested?
- Catinfo tool and discussion with physician and discussion with physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Age 18 and older
- First eye to be operated
- No previous ophthalmic surgery
- written informed consent to participation in the study
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery
Vienna, State of Vienna, 1140
About this study
Official title: Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery:
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.
Read the detailed description
Informing the patient and obtaining the informed consent is one of the major duties physicians perform before beginning a medical treatment. At the same time expectations of patients in modern medicine grow and so do the legal requirements on informing the patient. Studies have shown that patients often cannot remember the most important and essential parts of the communication with their physician.
It also appears that the use of printed information sheets providing patient information has not really changed this situation.
By the law of many countries, the duty to inform the patient has to be carried out in a personal face-to face communication of patient and physician. Frequently, the informed consent of the patient is documented by signature on printed forms and only a brief discussion is performed. Additionally, due to the asymmetry in the relationship between patient and physician, patients will often hesitate to ask questions in case of poor understanding of either their diagnosis or the planned procedure. Therefore, the informed consent process may not be sufficient to satisfy the patient's needs.
All these factors can result in misunderstandings, poor comprehension of the planned procedure and dissatisfied patients and may eventually lead to litigation.
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. This difference will then be evaluated together with the result of the Multiple choice questionnaire (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.
Patients will be randomly allocated to the study or the control group. Additionally all patients will be called one month after surgery to assess their satisfaction with the informed consent process.
- Conditions
- Patients' Information Level About Cataract Surgery, Patients' Attitude Before and After Cataract Surgery
- Being tested
- Catinfo tool and discussion with physician, discussion with physician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catinfo tool and discussion with physicianOther
Patients in the study group watch a computer presentation with information about the cataract surgery
discussion with physicianOther
Patients in the control group have a discussion with the physician
| Study group | Role | What they receive |
|---|---|---|
| Catinfo and discussion group | Active comparator | Patients watch a short computer presentation on the Catinfo tool before the discussion with the physician Receives: Other: Catinfo tool and discussion with physician |
| Discussion group | Active comparator | Patients have the standard discussion with the physician Receives: Other: discussion with physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients' attitude before and after cataract surgery
assessed by validated questionnaires
Measured: one month
Secondary outcomes (1)
- Difference concerning duration of the face to face interview with the physician between both groups
measured in seconds
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startSep 2010
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients' Information Level About Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167576
- Sponsor's protocol ID
- CAT
- Status last verified
- Sep 2010
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery:
- ClinicalTrials.gov ID
- NCT07167576
- Acronym / sponsor ID
- CAT
- Conditions
- Patients' Information Level About Cataract Surgery, Patients' Attitude Before and After Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Informing the patient and obtaining the informed consent is one of the major duties physicians perform before beginning a medical treatment. At the same time expectations of patients in modern medicine grow and so do the legal requirements on informing the patient. Studies have shown that patients often cannot remember the most important and essential parts of the communication with their physician.
It also appears that the use of printed information sheets providing patient information has not really changed this situation.
By the law of many countries, the duty to inform the patient has to be carried out in a personal face-to face communication of patient and physician. Frequently, the informed consent of the patient is documented by signature on printed forms and only a brief discussion is performed. Additionally, due to the asymmetry in the relationship between patient and physician, patients will often hesitate to ask questions in case of poor understanding of either their diagnosis or the planned procedure. Therefore, the informed consent process may not be sufficient to satisfy the patient's needs.
All these factors can result in misunderstandings, poor comprehension of the planned procedure and dissatisfied patients and may eventually lead to litigation.
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. This difference will then be evaluated together with the result of the Multiple choice questionnaire (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.
Patients will be randomly allocated to the study or the control group. Additionally all patients will be called one month after surgery to assess their satisfaction with the informed consent process.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catinfo and discussion group | Active comparator | Other: Catinfo tool and discussion with physicianPatients watch a short computer presentation on the Catinfo tool before the discussion with the physician |
| Discussion group | Active comparator | Other: discussion with physicianPatients have the standard discussion with the physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cataract
- Age 18 and older
- First eye to be operated
- No previous ophthalmic surgery
- written informed consent to participation in the study
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catinfo tool and discussion with physicianPatients in the study group watch a computer presentation with information about the cataract surgery | Other | Catinfo and discussion group |
| discussion with physicianPatients in the control group have a discussion with the physician | Other | Discussion group |
Primary outcome
patients' attitude before and after cataract surgery
Time frame: one month
assessed by validated questionnaires
1 secondary outcome
- Difference concerning duration of the face to face interview with the physician between both groups
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl, MD principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catinfo tool and discussion with physician and discussion with physician in people with Patients' Information Level About Cataract Surgery and Patients' Attitude Before and After Cataract Surgery, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patients' attitude before and after cataract surgery (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.