Prediction of Pseudophakodonesis of Intraocular Lenses
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 21, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 23, 2018
November 1, 2018
1.6 years
November 21, 2018
November 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (1)
Best corrected distance visual acuity (BCDVA)
12 months
Study Arms (1)
Pseudoexfoliation syndrome
EXPERIMENTALPatients with pseudoexfoliation syndrome or traumatic cataract will be examined using the Purkinjemeter device concerning IOL wobble, tilt and decentration
Interventions
The Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2018
First Posted
November 23, 2018
Study Start
May 1, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
November 23, 2018
Record last verified: 2018-11