CataractNCT03297086
Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
A study testing cataract surgery in people with Cataract and Presbyopia, run by Semmelweis University.
Trial summary
The purpose of this study is to evaluate possible changes of angle kappa after multifocal intraocular lens implantation. Presumable influencing factors of postoperative visual axis shift (ie. biometric parameters of the eye) are investigated to determine the degree and direction of angle kappa alterations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2015to 11 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age related cataract and presbyopia
Who cannot join
- Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated pupils, or known zonular weakness and corneal astigmatism >1.5 diopters were excluded from the study.
About this study
The purpose of this study is to evaluate possible changes of angle kappa after multifocal intraocular lens implantation. Presumable influencing factors of postoperative visual axis shift (ie. biometric parameters of the eye) are investigated to determine the degree and direction of angle kappa alterations.
Read the detailed description
The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular lens implantation.
During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are implanted. Optical biometry is carried out for IOL calculation and to measure axial length and angle kappa. Three months after surgery biometry is repeated, IOL position and angle kappa are measured using Scheimpflug-camera.
- Conditions
- Cataract, Presbyopia
- Being tested
- cataract surgery
- Keywords
- multifocal intraocular lens, angle kappa, presbyopia
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Bi-Flex | Active comparator | Medicontur Bi-Flex 677MY IOL was implanted into 24 eyes of 12 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured. Receives: Procedure: cataract surgery |
| ReStor | Active comparator | and Alcon Acrysof Restor SN6AD1 IOL was implanted into 36 eyes of 18 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured. Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of changes of angle kappa after multifocal intraocular lens implantation.
Changes in magnitude and orientation of angle kappa (deviation between the visual and pupillary axis) are measured before and after cataract surgery with multifoocal intraocular lens implantation. During pre-and postoperative examination optical biometry is carried out using Lenstar LS 900. Optical biometer determines deviation between the visual and pupillary axis that represents angle kappa. Deviation of these axes can be defined by its magnitude and orientation. Location of the pupil centre relative to the visual axis - the reference axis - is determined by x- and y-offsets using trigonometrical analysis.
Measured: 3 months
Secondary outcomes (2)
Determination of influencing effect of biometrical data on postoperative visual axis shift
Biometry data (axial length, keratometry, lens thickness, anterior chamber depth) are measured preoperatively by Lenstar LS 900 optical biometer. Their effect on changes of angle kappa is determined using statistical analysis.
Measured: 3 months
Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift
Three months after cataract surgery postoperative intraocular lens (IOL) position is determined using a rotating Scheimpflug-camera (Galilei G4). IOL decentration is obtained from the distance between the IOL centre and visual axis. The effect of possible IOL decentration on changes of angle kappa is determined using statistical analysis.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Dec 2015
- Primary completion25 Feb 2016
- Study completion11 Sep 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.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Medicontur Kft
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297086
- Sponsor's protocol ID
- Kappa1
- Status last verified
- Sep 2017
- First submitted
- 12 Sep 2017
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Angle Kappa After Implantation of Multifocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT03297086
- Acronym / sponsor ID
- Kappa1
- Conditions
- Cataract, Presbyopia
- Keywords
- multifocal intraocular lens, angle kappa, presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Medicontur Kft
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 29 Sep 2017 (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 purpose of this study is to evaluate possible changes of angle kappa after multifocal intraocular lens implantation. Presumable influencing factors of postoperative visual axis shift (ie. biometric parameters of the eye) are investigated to determine the degree and direction of angle kappa alterations.
Detailed description
The purpose of this study is to evaluate changes of angle kappa after multifocal intraocular lens implantation.
During cataract surgery Medicontur Bi-Flex 677MY IOL and Alcon Acrysof Restor SN6AD1 IOL are implanted. Optical biometry is carried out for IOL calculation and to measure axial length and angle kappa. Three months after surgery biometry is repeated, IOL position and angle kappa are measured using Scheimpflug-camera.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bi-Flex | Active comparator | Procedure: cataract surgeryMedicontur Bi-Flex 677MY IOL was implanted into 24 eyes of 12 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured. |
| ReStor | Active comparator | Procedure: cataract surgeryand Alcon Acrysof Restor SN6AD1 IOL was implanted into 36 eyes of 18 patients during cataract surgery. Angle kappa, biometric data and IOL decantation were measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with age related cataract and presbyopia
Key exclusion criteria (1 listed)
- Patients with previous ocular surgery, trauma, active ocular disease, poorly dilated pupils, or known zonular weakness and corneal astigmatism >1.5 diopters were excluded from the study.
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 |
|---|---|---|
| cataract surgerycataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens | Procedure or surgery | Bi-Flex, ReStor |
Primary outcome
Measurement of changes of angle kappa after multifocal intraocular lens implantation.
Time frame: 3 months
Changes in magnitude and orientation of angle kappa (deviation between the visual and pupillary axis) are measured before and after cataract surgery with multifoocal intraocular lens implantation. During pre-and postoperative examination optical biometry is carried out using Lenstar LS 900. Optical biometer determines deviation between the visual and pupillary axis that represents angle kappa. Deviation of these axes can be defined by its magnitude and orientation. Location of the pupil centre relative to the visual axis - the reference axis - is determined by x- and y-offsets using trigonometrical analysis.
2 secondary outcomes
Determination of influencing effect of biometrical data on postoperative visual axis shift
Time frame: 3 months
Determination of influencing effect of intraocular lens decentration on postoperative visual axis shift
Time frame: 3 months
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 29 Sep 2017.
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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?
A study testing cataract surgery in people with Cataract and Presbyopia, run by Semmelweis University.
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 1 inclusion and 1 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 29 Sep 2017. 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?
Measurement of changes of angle kappa after multifocal intraocular lens implantation. (time frame: 3 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 29 Sep 2017.