PseudoaphakiaNDysNCT04224129
Characterization and Causative Factors of Negative Dysphotopsia
An observational study of Pseudoaphakia, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
The present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pseudoaphakia
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2016to May 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients after cataract extraction, suffering from negative dysphotopsia
Who may be able to join
- Pseudophakic
- Recurrently and persistently reporting about negative dysphotopsia
- Age 21 and older
- written informed consent prior to entering the study
Who cannot join
- Relevant ophthalmic diseases such as: glaucoma, (previous) traumatic cataract, corneal scars, age-related macular degeneration and other pathologies resulting in visual field defects
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Hanusch-Krankenhaus
Vienna, A-1140
Oliver Findl, MD, MBA, +431 910 21 84611, oliver@findl.at
Oliver Findl, MD, MBA
About this study
Official title: Defining and Quantifying Negative Dysphotopsia Characterization and Causative Factors of Negative Dysphotopsia
The present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon.
- Conditions
- Pseudoaphakia
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of factors or a combination thereof that may cause negative dysphotopsia
Biometry, Anamnesis, visual field, psychological questionnaires, wavefront aberrometry will be used to analyse if a factor causative for negative dysphotopsia can be detected
Measured: 2 hours
Secondary outcomes (2)
Method to standardize characterization of negative dysphotopsia
New approaches like Goldmann visual field are used to try to picture negative dysphotopsias and patients will also be asked to draw the "dark shadows"
Measured: 20 minutes
Correlation between eye biometry, patient complaints and psychophysics
Eye biometry will be measured using IOL Master 700, patient complaints will be asked during an patient-doctor interview, and psychophysics will be assessed using a psychological questionnaire
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startJan 2016
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudoaphakiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 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, Prof., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224129
- Sponsor's protocol ID
- NDys
- Acronym
- NDys
- Status last verified
- Jan 2020
- First submitted
- 11 Apr 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining and Quantifying Negative Dysphotopsia Characterization and Causative Factors of Negative Dysphotopsia
- ClinicalTrials.gov ID
- NCT04224129
- Acronym / sponsor ID
- NDys / NDys
- Conditions
- Pseudoaphakia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 13 Jan 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 present study is designed as an exploratory study, seeking to investigate the correlation of patient complaints to subjective or objective measurement methods. Better understanding of causative factors of negative dysphotopsia will improve detection and maybe prediction of this optical phenomenon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients after cataract extraction, suffering from negative dysphotopsia
Key inclusion criteria (4 listed)
- Pseudophakic
- Recurrently and persistently reporting about negative dysphotopsia
- Age 21 and older
- written informed consent prior to entering the study
Key exclusion criteria (2 listed)
- Relevant ophthalmic diseases such as: glaucoma, (previous) traumatic cataract, corneal scars, age-related macular degeneration and other pathologies resulting in visual field defects
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of factors or a combination thereof that may cause negative dysphotopsia
Time frame: 2 hours
Biometry, Anamnesis, visual field, psychological questionnaires, wavefront aberrometry will be used to analyse if a factor causative for negative dysphotopsia can be detected
2 secondary outcomes
Method to standardize characterization of negative dysphotopsia
Time frame: 20 minutes
Correlation between eye biometry, patient complaints and psychophysics
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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, Prof. 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?
An observational study of Pseudoaphakia, 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 4 inclusion and 2 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 13 Jan 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 Oliver Findl, MD, Prof. (004319102157564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of factors or a combination thereof that may cause negative dysphotopsia (time frame: 2 hours). 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 13 Jan 2020.