CataractNCT03453827
Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
An observational study of Cataract and Pseudoexfoliation Syndrome, run by Hospital Hietzing.
Trial summary
To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Cataract, Pseudoexfoliation Syndrome, Pseudophakia
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 28 Apr 2017
- 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 18 to 125 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent standard procedure cataract surgery with or without Pseudoexfoliation Syndrome.
Who may be able to join
- patients 4-6 years after standard cataract surgery
- pseudoexfoliation Syndrome (PES)
Who cannot join
- Diabetic retinopathy
- Age related macula Degeneration
- retinal bloodvessel disease
About this study
Official title: Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.
Read the detailed description
64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.
- Conditions
- Cataract, Pseudoexfoliation Syndrome, Pseudophakia
- Being tested
- no intervention
- Keywords
- Pseudoexfoliation Syndrome, Cataract, Aberration, IOL decentration, IOL tilt
- Medical subject headings
- Cataract, Exfoliation Syndrome, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| PEX | Patients after Cataract surgery with PES Receives: Other: no intervention | |
| Control | Patients after Cataract surgery without PES Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOL decentration
decentration of IOL is measured using Hoya iTrace
Measured: 4-6 years after cataract surgery
IOL tilt
tilt of implanted IOL is measured using Hoya iTace
Measured: 4-6 years after cataract surgery
IOL decentration
decentration of IOL is measured using Zeiss OCT
Measured: 4-6 years after cataract surgery
IOL tilt
tilt of implanted IOL is measured using Zeiss OCT
Measured: 4-6 years after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Apr 2016
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Hietzing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kata Mihaltz, Hospital Hietzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453827
- Sponsor's protocol ID
- PEX Study
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT03453827
- Acronym / sponsor ID
- PEX Study
- Conditions
- Cataract, Pseudoexfoliation Syndrome, Pseudophakia
- Keywords
- Pseudoexfoliation Syndrome, Cataract, Aberration, IOL decentration, IOL tilt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospital HietzingUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 5 Mar 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.
To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.
Detailed description
64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEX | – | Other: no interventionPatients after Cataract surgery with PES |
| Control | – | Other: no interventionPatients after Cataract surgery without PES |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent standard procedure cataract surgery with or without Pseudoexfoliation Syndrome.
Key inclusion criteria (2 listed)
- patients 4-6 years after standard cataract surgery
- pseudoexfoliation Syndrome (PES)
Key exclusion criteria (3 listed)
- Diabetic retinopathy
- Age related macula Degeneration
- retinal bloodvessel disease
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 |
|---|---|---|
| no interventionno intervention | Other | Control, PEX |
Primary outcome
IOL decentration
Time frame: 4-6 years after cataract surgery
decentration of IOL is measured using Hoya iTrace
IOL tilt
Time frame: 4-6 years after cataract surgery
tilt of implanted IOL is measured using Hoya iTace
IOL decentration
Time frame: 4-6 years after cataract surgery
decentration of IOL is measured using Zeiss OCT
IOL tilt
Time frame: 4-6 years after cataract surgery
tilt of implanted IOL is measured using Zeiss OCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Pseudoexfoliation Syndrome, run by Hospital Hietzing.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOL decentration (time frame: 4-6 years after cataract surgery). The study lists 4 primary outcomes in all. 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 8 Mar 2018.