CataractNCT05215002
Quality Assurance Via Telephone Interviews After Cataract Surgery
A study testing Telephone Call and No telephone call in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Telephone Call and No telephone call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- 19 Nov 2019to 1 Nov 2023
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital
Vienna, 1140
Oliver Findl, MD, +43 (1) 91021 ext. 57564, office@viros.at
Manuel Ruiss, MSc, +43 (1) 91021 ext. 57564, office@viros.at
About this study
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.
Read the detailed description
As there is a trend towards shorter hospital stays, an increasing number of patients is leaving the hospital the same day after cataract surgery. There may be questions or complaints after the patients' dismissal after cataract surgery, consequently it might be useful to call patients at the day or one day after surgery in order to ask them about their concerns.
In general, possible complications after cataract surgery are explained to patients already before surgery and patients often receive additional written information. But as patients may still be uncertain whether it would be beneficial to visit a doctor in case of problems, it might be useful to call the patients and if necessary, advise them to see a doctor. During the phone call patients have the opportunity to ask more questions if something still does not seem clear.
For patients who are scheduled for cataract surgery for both eyes, the routine procedure is as follows: if cataract surgery is scheduled for both eyes, in general the surgeries are performed one week apart. Cataract surgery is usually performed under local anaesthesia and the patient can leave the department on the same day. When patients arrive at the department of ophthalmology for the second surgery, doctors evaluate the condition of the eye, operated the week before. After each surgery of each eye patients receive a prescription of topical medication. It is recommended to see the referring ophthalmologist within a week after the procedure. In case of problems or complaints patients are always told to see a doctor immediately. A respective written information is given to the patients.
During this study we plan to call patients, who are scheduled for cataract surgery for both eyes, in the evening of the day of the surgery or one day after the surgery of the first eye and to ask questions about their current condition for quality assessment. When people return for cataract surgery of the second eye, a questionnaire will be handed out to the patients. This questionnaire includes questions concerning problems after surgery of the first eye, visits in outpatint clinics and about their satisfaction with the phone call after the surgery of the first eye.
In this study 200 patients will be included: 100 patients will receive a telephone call (50 in the evening of the day of the surgery, 50 one day after surgery) and 100 patients who will not receive a phone call.
- Conditions
- Cataract
- Being tested
- Telephone Call, No telephone call
- Keywords
- Telephone Call
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Telephone call | Experimental | Patient will receive a telephone call in the evening of the day of the surgery or one day after surgery Receives: 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 Receives: Other: No telephone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (2)
Patient's Satisfaction
Patient's satisfaction with the telephone call after cataract surgery will be assessed with a question asking the patient if she/ he liked the call (5 answering options: very, a little, I don't know, no, absolutely not)
Measured: 24 months
Patient's Symptoms
Patient's symptoms after cataract surgery will be assessed during the telephone interview and the questionnaire
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start19 Nov 2019
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- NCT05215002
- Sponsor's protocol ID
- Cat Tel
- Status last verified
- Jan 2022
- First submitted
- 18 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assurance Via Telephone Interviews After Cataract Surgery
- ClinicalTrials.gov ID
- NCT05215002
- Acronym / sponsor ID
- Cat Tel
- Conditions
- Cataract
- Keywords
- Telephone Call
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 31 Jan 2022 (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.
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.
Detailed description
As there is a trend towards shorter hospital stays, an increasing number of patients is leaving the hospital the same day after cataract surgery. There may be questions or complaints after the patients' dismissal after cataract surgery, consequently it might be useful to call patients at the day or one day after surgery in order to ask them about their concerns.
In general, possible complications after cataract surgery are explained to patients already before surgery and patients often receive additional written information. But as patients may still be uncertain whether it would be beneficial to visit a doctor in case of problems, it might be useful to call the patients and if necessary, advise them to see a doctor. During the phone call patients have the opportunity to ask more questions if something still does not seem clear.
For patients who are scheduled for cataract surgery for both eyes, the routine procedure is as follows: if cataract surgery is scheduled for both eyes, in general the surgeries are performed one week apart. Cataract surgery is usually performed under local anaesthesia and the patient can leave the department on the same day. When patients arrive at the department of ophthalmology for the second surgery, doctors evaluate the condition of the eye, operated the week before. After each surgery of each eye patients receive a prescription of topical medication. It is recommended to see the referring ophthalmologist within a week after the procedure. In case of problems or complaints patients are always told to see a doctor immediately. A respective written information is given to the patients.
During this study we plan to call patients, who are scheduled for cataract surgery for both eyes, in the evening of the day of the surgery or one day after the surgery of the first eye and to ask questions about their current condition for quality assessment. When people return for cataract surgery of the second eye, a questionnaire will be handed out to the patients. This questionnaire includes questions concerning problems after surgery of the first eye, visits in outpatint clinics and about their satisfaction with the phone call after the surgery of the first eye.
In this study 200 patients will be included: 100 patients will receive a telephone call (50 in the evening of the day of the surgery, 50 one day after surgery) and 100 patients who will not receive a phone call.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone call | Experimental | Other: Telephone CallPatient will receive a telephone call in the evening of the day of the surgery or one day after surgery |
| No telephone call | Experimental | Other: No telephone callPatient will not receive a telephone call in the evening of the day of the surgery or one day after surgery |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women aged 18 and older
- planned cataract surgery of both eyes
- good knowledge of the german language
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telephone CallPatient will be called in the evening of the day of the surgery or one day after surgery and asked about any complaints | Other | Telephone call |
| No telephone callPatient will not be called in the evening of the day of the surgery or one day after surgery and asked about any complaints | Other | No telephone call |
Primary outcome
Number of patients
Time frame: 24 months
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
2 secondary outcomes
Patient's Satisfaction
Time frame: 24 months
Patient's Symptoms
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Individual participant dataSharing planned: No
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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 Telephone Call and No telephone call in people with Cataract, 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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Findl, MD (+43 (1) 91021 ext. 57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients (time frame: 24 months). 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 14 Feb 2022.