CataractNCT03751462
Prediction of Pseudophakodonesis of Intraocular Lenses
A study testing Purkinjemeter in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
Compare visual acuity of patients after cataract surgery with implantation of an IOL clinical outcome measure in eyes with and without pseudoexfoliation syndrome or history of ocular trauma. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Purkinjemeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2018to 1 Dec 2019
- 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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract with the indication for surgery (decrease in visual acuity, blurred vision or glare ) for both groups (study and control group)
- Age 18 and older
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Written informed consent
- Pseudoexfoliation syndrome or history of blunt ocular trauma - for the study group
Who cannot join
- Pseudoexfoliation syndrome or history of blunt ocular trauma - for the control group
- History of penetrating ocular trauma
- Relevant other ophthalmic diseases that could affect corneal transparency or the ability for fixation
- Any relevant ophthalmic disease leading to limited visual acuity prognosis after cataract surgery
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
Sophie Mädel, MD, 01 91021-57564, office@viros.at
Nino Hirnschall, MD, 01 91021-57564, office@viros.at
About this study
Official title: Prediction of Pseudophakodonesis After Uneventful Cataract Surgery
Compare visual acuity of patients after cataract surgery with implantation of an IOL clinical outcome measure in eyes with and without pseudoexfoliation syndrome or history of ocular trauma.
Read the detailed description
Cataract surgery ist the most often performed surgery worldwide and with increasing number of patients undergoing surgery, patients' expectations concerning postoperative optical outcomes are growing. In order to achieve an optimal outcome after cataract surgery an adequate intraocular lens (IOL) centration is essential, especially when premium IOLs like aspheric, toric or multifocal IOls are being implanted. This fact has to be kept in mind especially in patients with pseudoexfoliation syndrome (PXF) or with history of blunt ocular trauma, where decentration and subluxation of the IOL is more likely due to a higher incidence of zonular weakness and zonular dialysis.
Additionally, pseudophacodonesis - dangling of the IOL with eye movement - can occur. Decentration, tilt and dangling of the IOL may decrease visual acuity and contrast sensitivity and induce glare and subjective perception of image flickering. Because of the large amount of pseudophakic patients worldwide, decentered and dislocated IOLs may cause a relatively large public health care burden.
Additionally, IOL implantation in eyes with zonular pathology may be technically challenging. Several devices to improve IOL stability in demanding eyes have been developed and may be used in cases lacking sufficient zonular support, such as different capsular tension rings. Another option would be to use special surgical techniques like scleral fixation of the IOL.
In pseudophakic eyes, IOL tilt and decentration may be measured as an indicator for zonular stability. Several techniques have been used to measure IOL decentration and tilt, such as slitlamp examination, retroillumination photography, Scheimpflug imaging and the analysis of purkinje reflexes. Slitlamp examination is a subjective method that allows approximate decentration measurements, but no quantitative tilt measurements. For this measurement the pupil has to be dilated. Scheimpflug imaging also needs a sufficiently dilated pupil to make the optic edge and the posterior surface of the IOL visible. A recently developed purkinje meter was shown to be highly reproducible to assess IOL tilt and decentration. A new version of this purkinje meter can additionally acquire videos of eye movements. Analysis of these dynamic images can detect dangling or "wobbling" of the lens capsule and the IOL.
Patients within this study will be examined on two occasions. Only one additional visit will be necessary as the first examination will take place on the day of the routine pre-operative visit and all measurements will be non invasive. The results will lead to a better understanding of the long-term outcome after implanting IOLs in eyes with pseudoexfoliation syndrome or a ocular trauma.
- Conditions
- Cataract
- Being tested
- Purkinjemeter
- Keywords
- Cataract, Pseudoexfoliation, Traumatic cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PurkinjemeterDevice
The Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract
| Study group | Role | What they receive |
|---|---|---|
| Pseudoexfoliation syndrome | Experimental | Patients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration Receives: Device: Purkinjemeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL wobble
IOL wobble, tilt and decentration will be assessed in patients with PEX or traumatic cataract using the Purkinjemeter device. The smaller the amount of IOL wobble, tilt and decentration, the better the results.
Measured: 12 months
Secondary outcomes (1)
Best corrected distance visual acuity (BCDVA)
BCDVA will be assessed using a ETDRS chart in 4 meters distance. The more words the patient can read, the better the outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 May 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751462
- Sponsor's protocol ID
- Pseudophakodonesis
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pseudophakodonesis After Uneventful Cataract Surgery
- ClinicalTrials.gov ID
- NCT03751462
- Acronym / sponsor ID
- Pseudophakodonesis
- Conditions
- Cataract
- Keywords
- Cataract, Pseudoexfoliation, Traumatic cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 23 Nov 2018 (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.
Compare visual acuity of patients after cataract surgery with implantation of an IOL clinical outcome measure in eyes with and without pseudoexfoliation syndrome or history of ocular trauma.
Detailed description
Cataract surgery ist the most often performed surgery worldwide and with increasing number of patients undergoing surgery, patients' expectations concerning postoperative optical outcomes are growing. In order to achieve an optimal outcome after cataract surgery an adequate intraocular lens (IOL) centration is essential, especially when premium IOLs like aspheric, toric or multifocal IOls are being implanted. This fact has to be kept in mind especially in patients with pseudoexfoliation syndrome (PXF) or with history of blunt ocular trauma, where decentration and subluxation of the IOL is more likely due to a higher incidence of zonular weakness and zonular dialysis.
Additionally, pseudophacodonesis - dangling of the IOL with eye movement - can occur. Decentration, tilt and dangling of the IOL may decrease visual acuity and contrast sensitivity and induce glare and subjective perception of image flickering. Because of the large amount of pseudophakic patients worldwide, decentered and dislocated IOLs may cause a relatively large public health care burden.
Additionally, IOL implantation in eyes with zonular pathology may be technically challenging. Several devices to improve IOL stability in demanding eyes have been developed and may be used in cases lacking sufficient zonular support, such as different capsular tension rings. Another option would be to use special surgical techniques like scleral fixation of the IOL.
In pseudophakic eyes, IOL tilt and decentration may be measured as an indicator for zonular stability. Several techniques have been used to measure IOL decentration and tilt, such as slitlamp examination, retroillumination photography, Scheimpflug imaging and the analysis of purkinje reflexes. Slitlamp examination is a subjective method that allows approximate decentration measurements, but no quantitative tilt measurements. For this measurement the pupil has to be dilated. Scheimpflug imaging also needs a sufficiently dilated pupil to make the optic edge and the posterior surface of the IOL visible. A recently developed purkinje meter was shown to be highly reproducible to assess IOL tilt and decentration. A new version of this purkinje meter can additionally acquire videos of eye movements. Analysis of these dynamic images can detect dangling or "wobbling" of the lens capsule and the IOL.
Patients within this study will be examined on two occasions. Only one additional visit will be necessary as the first examination will take place on the day of the routine pre-operative visit and all measurements will be non invasive. The results will lead to a better understanding of the long-term outcome after implanting IOLs in eyes with pseudoexfoliation syndrome or a ocular trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pseudoexfoliation syndrome | Experimental | Device: PurkinjemeterPatients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cataract with the indication for surgery (decrease in visual acuity, blurred vision or glare ) for both groups (study and control group)
- Age 18 and older
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Written informed consent
- Pseudoexfoliation syndrome or history of blunt ocular trauma - for the study group
Key exclusion criteria (5 listed)
- Pseudoexfoliation syndrome or history of blunt ocular trauma - for the control group
- History of penetrating ocular trauma
- Relevant other ophthalmic diseases that could affect corneal transparency or the ability for fixation
- Any relevant ophthalmic disease leading to limited visual acuity prognosis after cataract surgery
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
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 |
|---|---|---|
| PurkinjemeterThe Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract | Device | Pseudoexfoliation syndrome |
Primary outcome
IOL wobble
Time frame: 12 months
IOL wobble, tilt and decentration will be assessed in patients with PEX or traumatic cataract using the Purkinjemeter device. The smaller the amount of IOL wobble, tilt and decentration, the better the results.
1 secondary outcome
Best corrected distance visual acuity (BCDVA)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Purkinjemeter in people with Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA 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 5 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 Nov 2018. 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 Sophie Mädel, MD (01 91021-57564, office@viros.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL wobble (time frame: 12 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 Nov 2018.