Prediction of Pseudophakodonesis of Intraocular Lenses
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Purkinjemeter
Sponsored by

About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Pseudoexfoliation, Traumatic cataract
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pseudoexfoliation syndrome
Arm Description
Patients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03751462
First Posted
November 21, 2018
Last Updated
November 21, 2018
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
1. Study Identification
Unique Protocol Identification Number
NCT03751462
Brief Title
Prediction of Pseudophakodonesis of Intraocular Lenses
Official Title
Prediction of Pseudophakodonesis After Uneventful Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract, Pseudoexfoliation, Traumatic cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pseudoexfoliation syndrome
Arm Type
Experimental
Arm Description
Patients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration
Intervention Type
Device
Intervention Name(s)
Purkinjemeter
Intervention Description
The Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract
Primary Outcome Measure Information:
Title
IOL wobble
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Best corrected distance visual acuity (BCDVA)
Description
BCDVA will be assessed using a ETDRS chart in 4 meters distance. The more words the patient can read, the better the outcome.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie Mädel, MD
Phone
01 91021-57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD
Phone
01 91021-57564
Email
office@viros.at
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Mädel, MD
Phone
01 91021-57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
Phone
01 91021-57564
Email
office@viros.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prediction of Pseudophakodonesis of Intraocular Lenses
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