Senile CataractNCT04468308
VRQOL in Cataract Patients During the COVID-19 Pandemic
An observational study of Senile Cataract, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Senile Cataract
- What is being tested?
- Questionnaire
- How many people
- 116 participants
- Where
- 1 siteAustria
- Study dates
- 8 Sep 2020to Mar 2021
- Phase
- Observational
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: Patients with senile cataract with indication for for unilateral or bilateral cataract surgery.
Who may be able to join
- Age ≥ 50 years
- Senile cataract
- Indication for unilateral or bilateral cataract surgery
- Postponed cataract surgery due to the COVID-19 pandemic
- Signed and dated declaration of consent
Who cannot join
- Complex form of cataract (traumatic cataract, secondary cataract after intraocular inflammation)
- Amblyopia on the eye that is to be operated on
- Severe, visually impairing eye disease on the eye that is to operated on
- Known dementia or memory problems
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Teresa Rauchegger, Dr., +43 512 504 24184, teresa.rauchegger@i-med.ac.at
Claus Zehetner, Dr., +43 512 504 24184, claus.zehetner@i-med.ac.at
About this study
Official title: Assessment of Vision-related Quality of Life (VRQOL) in Cataract Patients During the COVID-19 Pandemic
The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.
- Conditions
- Senile Cataract
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Patients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Senile Cataract | Patient with senile cataract, whose cataract surgery was postponed in the COVID-19 pandemic Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement Vision-related quality of life
Extent of improvement of vision-related qualitiy of life due to cataract surgery measured with the National Eye Institut Visual Function Questionnaire 25.
Measured: 3 months
Secondary outcomes (2)
Delay of Vision-related quality of life
Delay of improvement of vision-related qualitiy of life in the COVID-19 pandemic measured in days between the originally scheduled operation and the actual operation date
Measured: 3 months
Visual acuity
Visual acuity difference between visual acuity at the time of indication for cataract surgery, on the day of surgery and one month postoperatively.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start8 Sep 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile CataractStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468308
- Sponsor's protocol ID
- VRQOL Cataract COVID-19
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 23 Sep 2020
- 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 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vision-related Quality of Life (VRQOL) in Cataract Patients During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04468308
- Acronym / sponsor ID
- VRQOL Cataract COVID-19
- Conditions
- Senile Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 13 Jul 2020 (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.
The aim of this questionnaire survey is to evaluate the improvement in vision-related quality of life before and after cataract surgery using the National Eye Institute Visual Function Questionnaire 25 and the delay of improvement in the COVID-19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Senile Cataract | – | Other: QuestionnairePatient with senile cataract, whose cataract surgery was postponed in the COVID-19 pandemic |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with senile cataract with indication for for unilateral or bilateral cataract surgery.
Key inclusion criteria (5 listed)
- Age ≥ 50 years
- Senile cataract
- Indication for unilateral or bilateral cataract surgery
- Postponed cataract surgery due to the COVID-19 pandemic
- Signed and dated declaration of consent
Key exclusion criteria (4 listed)
- Complex form of cataract (traumatic cataract, secondary cataract after intraocular inflammation)
- Amblyopia on the eye that is to be operated on
- Severe, visually impairing eye disease on the eye that is to operated on
- Known dementia or memory problems
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 |
|---|---|---|
| QuestionnairePatients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively. | Other | Senile Cataract |
Primary outcome
Improvement Vision-related quality of life
Time frame: 3 months
Extent of improvement of vision-related qualitiy of life due to cataract surgery measured with the National Eye Institut Visual Function Questionnaire 25.
2 secondary outcomes
Delay of Vision-related quality of life
Time frame: 3 months
Visual acuity
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Senile Cataract, run by Medical University Innsbruck 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 4 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 23 Sep 2020. 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 Teresa Rauchegger, Dr. (+43 512 504 23721, teresa.rauchegger@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement Vision-related quality of life (time frame: 3 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 23 Sep 2020.