AstigmatismNCT02370953
VERION Versus Conventional, Manual Ink-marking in Toric IOL Implantation
A study testing VERION for toric IOL alignment and Conventional, manual ink-marking for toric IOL alignment in people with Astigmatism, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
OVERVIEW Cataract is a clouding of the crystalline lens which causes vision loss and blindness if untreated. Cataract surgery is the most frequently performed surgical intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010 amounting to a total number of over 160.000 surgeries per… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- VERION for toric IOL alignment and Conventional, manual ink-marking for toric IOL alignment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2015to Feb 2016
- 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
- Astigmatism (at least 1.25D)
- Cataract
- Are at least 18 years of age
- Eye eligible to undergo cataract extraction
- Eye eligible for toric IOL implantation
- Bilateral eyes: availability to undergo second eye surgery within 2 weeks of the first eye surgery
- Willing and able to comply with scheduled visits and other study procedures
- Understand and signed informed consent
Who cannot join
- Irregular corneal astigmatism or keratoconus
- Extensive age related macular degeneration (atrophic or exudative AMD or numerous soft drusen)
- Fuchs endothelial dystrophy (stage 2)
- Uncontrolled/manifest glaucoma
- Glaucoma related extensive visual field loss
- Extensive diabetic macular disease
Show all 10Show fewer
- Previous intraocular or corneal surgery of any kind
- Subjects presenting any contraindications to cataract surgery
- Subjects with a recurrent or active ocular or uncontrolled eyelid disease
- Subjects with a history of lens instability (e.g. posterior polar cataract, traumatic cataract) or zonular instability
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6202 AZ
About this study
OVERVIEW Cataract is a clouding of the crystalline lens which causes vision loss and blindness if untreated. Cataract surgery is the most frequently performed surgical intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010 amounting to a total number of over 160.000 surgeries per year in the Netherlands.
Approximately 22% of patients with cataract have a substantial pre-existing corneal astigmatism. Toric IOLs provide the opportunity to correct pre-existing astigmatism, offering the patients optimum distance vision without the use of spectacles or contact lenses. Toric IOLs are increasingly used in cataract and refractive surgery.
Read more
Since the introduction of toric intraocular lenses (IOLs) in the treatment of cataract in patients with pre-existing corneal astigmatism, numerous studies have shown the importance of accurate positioning of the toric IOL to the intended alignment axis. An error of 5º in toric IOL alignment will decrease the anticipated effect by 17% and thus misalignment will decrease the effectiveness of the astigmatism treatment. There are several methods used to align the toric IOL at the intended axis. Most of these use a 3-step ink-marking procedure and are performed manually. Clinical study showed an average error of 5º in toric IOL alignment when using this method.
Two new tools that have recently been introduced to the market are the VERION Measurement Module and VERION Digital Marker. Together, these tools provide integrated digital guidance for alignment of toric IOLs and they have the potential to eliminate the error in horizontal axis marking and the alignment axis marking error. This will lead to an improved visual outcome. So far, there are no published studies using the VERION tools for toric IOL alignment in cataract surgery. Therefore, the investigators will perform this randomized control trial.
MAIN HYPOTHESIS
The investigators hypothesise that cataract surgery with the implantation of a toric IOL, when using the VERION-tools, compared to manual ink-marking, in patients with corneal astigmatism will lead to:
- An increase in accuracy in toric IOL alignment
OBJECTIVES
Primary Objective:
The primary objective of the study is to compare the accuracy in toric IOL alignment when using the VERION-tools for alignment of the toric IOL or the conventional manual ink-marking procedure.
Other hypotheses and objectives are available in the detailed description.
Read the detailed description
Extra hypotheses
- A decrease in residual astigmatism
- An improved best corrected distance visual acuity (BCVA)
- An improved uncorrected distance visual acuity (UCVA)
- A decrease in residual refractive astigmatism
- A decrease or comparable complication profile
Secondary Objective:
The secondary objective of the study is to compare residual astigmatism when using the VERION Measurement Module and VERION Digital Marker for alignment of the toric IOL or the conventional manual ink-marking procedure.
Other Secondary Objectives:
The other secondary objectives are to compare:
- Best corrected distance visual acuity (BCVA)
- Uncorrected distance visual acuity (UCVA)
- Residual refractive astigmatism
- Wavefront aberrations
- Complication profile
- Conditions
- Astigmatism
- Being tested
- VERION for toric IOL alignment, Conventional, manual ink-marking for toric IOL alignment
- Keywords
- Toric IOL alignment, VERION digital marker, Manual ink-marking, Randomized controlled trial
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERION for toric IOL alignmentDevice
Also called VERION Measurement Module and Digital Marker
The VERION Measurement Module is a diagnostic device which can make high resolution colour reference images of the patient's eye for position reference. The VERION Digital Marker is a medical device that assists the surgeon in planning and performing surgical procedures on the eye. The VERION tools use several reference points on the conjunctiva and limbus, and make an overlay between the preoperative achieved and live-surgery image. During surgery, this device projects the horizontal axis and the estimated placement axis of the toric IOL on the patient's eye, and therefore, the surgeon can accurately place the toric IOL to its preoperatively calculated angle.
Conventional, manual ink-marking for toric IOL alignmentProcedure or surgery
Also called Conventional, manual ink-marking
Several manually performed methods are used to align the toric IOL at the intended axis. Most of them use a 3-step procedure. First, the horizontal axis of the eye is temporarily marked with ink in a seated position to correct for cyclotorsion when changing into supine position. Three spots on the conjunctiva, close to the edge of the cornea, are applied at 0°, 90° and 180°, which may be done by using a bubblemarker or gravity marker with a calibrated horizontal position. Next, the desired alignment axis for the toric IOL is marked intra-operatively. The last step is to rotate the implanted toric IOL until the IOL markings agree with the alignment marks. After surgery is performed, the ink marks will disappear within a few hours.
| Study group | Role | What they receive |
|---|---|---|
| VERION | Experimental | In this group the VERION-tools (Digital Marker) are used for the alignment of the toric IOL Receives: Device: VERION for toric IOL alignment |
| Conventional, manual ink-marking | Active comparator | In the group the conventional manual marking is used for the alignment of the toric IOL Receives: Procedure: Conventional, manual ink-marking for toric IOL alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average error (in degrees) in toric IOL-axis
Measured: at week 13 (after the first surgery, if bilateral surgery was performed).
Secondary outcomes (1)
Percentage of eyes with residual refractive cylinder ≤0.5D
Measured: at week 13 (after the first surgery, if bilateral surgery was performed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudy Nuijts, MD, PhD, Principal investigator, Maastricht University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370953
- Sponsor's protocol ID
- NL51895.068.14
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
PubMed 18721707Visser N, Berendschot TT, Bauer NJ, Jurich J, Kersting O, Nuijts RM. Accuracy of toric intraocular lens implantation in cataract and refractive surgery. J Cataract Refract Surg. 2011 Aug;37(8):1394-402. doi: 10.1016/j.jcrs.2011.02.024.
PubMed 21782085Visser N, Berendschot TT, Verbakel F, de Brabander J, Nuijts RM. Comparability and repeatability of corneal astigmatism measurements using different measurement technologies. J Cataract Refract Surg. 2012 Oct;38(10):1764-70. doi: 10.1016/j.jcrs.2012.05.036.
PubMed 22999600
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VERION Versus Conventional, Manual Ink-marking in Toric IOL Implantation
- ClinicalTrials.gov ID
- NCT02370953
- Acronym / sponsor ID
- NL51895.068.14
- Conditions
- Astigmatism
- Keywords
- Toric IOL alignment, VERION digital marker, Manual ink-marking, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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.
OVERVIEW Cataract is a clouding of the crystalline lens which causes vision loss and blindness if untreated. Cataract surgery is the most frequently performed surgical intervention in medicine with an incidence of 880 surgeries per 100.000 population in 2010 amounting to a total number of over 160.000 surgeries per year in the Netherlands.
Approximately 22% of patients with cataract have a substantial pre-existing corneal astigmatism. Toric IOLs provide the opportunity to correct pre-existing astigmatism, offering the patients optimum distance vision without the use of spectacles or contact lenses. Toric IOLs are increasingly used in cataract and refractive surgery.
Since the introduction of toric intraocular lenses (IOLs) in the treatment of cataract in patients with pre-existing corneal astigmatism, numerous studies have shown the importance of accurate positioning of the toric IOL to the intended alignment axis. An error of 5º in toric IOL alignment will decrease the anticipated effect by 17% and thus misalignment will decrease the effectiveness of the astigmatism treatment. There are several methods used to align the toric IOL at the intended axis. Most of these use a 3-step ink-marking procedure and are performed manually. Clinical study showed an average error of 5º in toric IOL alignment when using this method.
Two new tools that have recently been introduced to the market are the VERION Measurement Module and VERION Digital Marker. Together, these tools provide integrated digital guidance for alignment of toric IOLs and they have the potential to eliminate the error in horizontal axis marking and the alignment axis marking error. This will lead to an improved visual outcome. So far, there are no published studies using the VERION tools for toric IOL alignment in cataract surgery. Therefore, the investigators will perform this randomized control trial.
MAIN HYPOTHESIS
The investigators hypothesise that cataract surgery with the implantation of a toric IOL, when using the VERION-tools, compared to manual ink-marking, in patients with corneal astigmatism will lead to:
- An increase in accuracy in toric IOL alignment
OBJECTIVES
Primary Objective:
The primary objective of the study is to compare the accuracy in toric IOL alignment when using the VERION-tools for alignment of the toric IOL or the conventional manual ink-marking procedure.
Other hypotheses and objectives are available in the detailed description.
Detailed description
Extra hypotheses
- A decrease in residual astigmatism
- An improved best corrected distance visual acuity (BCVA)
- An improved uncorrected distance visual acuity (UCVA)
- A decrease in residual refractive astigmatism
- A decrease or comparable complication profile
Secondary Objective:
The secondary objective of the study is to compare residual astigmatism when using the VERION Measurement Module and VERION Digital Marker for alignment of the toric IOL or the conventional manual ink-marking procedure.
Other Secondary Objectives:
The other secondary objectives are to compare:
- Best corrected distance visual acuity (BCVA)
- Uncorrected distance visual acuity (UCVA)
- Residual refractive astigmatism
- Wavefront aberrations
- Complication profile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VERION | Experimental | Device: VERION for toric IOL alignmentIn this group the VERION-tools (Digital Marker) are used for the alignment of the toric IOL |
| Conventional, manual ink-marking | Active comparator | Procedure: Conventional, manual ink-marking for toric IOL alignmentIn the group the conventional manual marking is used for the alignment of the toric IOL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Astigmatism (at least 1.25D)
- Cataract
- Are at least 18 years of age
- Eye eligible to undergo cataract extraction
- Eye eligible for toric IOL implantation
Key exclusion criteria (10 listed)
- Irregular corneal astigmatism or keratoconus
- Extensive age related macular degeneration (atrophic or exudative AMD or numerous soft drusen)
- Fuchs endothelial dystrophy (stage 2)
- Uncontrolled/manifest glaucoma
- Glaucoma related extensive visual field loss
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 |
|---|---|---|
| VERION for toric IOL alignmentAlso: VERION Measurement Module and Digital MarkerThe VERION Measurement Module is a diagnostic device which can make high resolution colour reference images of the patient's eye for position reference. The VERION Digital Marker is a medical device that assists the surgeon in planning and performing surgical procedures on the eye. The VERION tools use several reference points on the conjunctiva and limbus, and make an overlay between the preoperative achieved and live-surgery image. During surgery, this device projects the horizontal axis and the estimated placement axis of the toric IOL on the patient's eye, and therefore, the surgeon can accurately place the toric IOL to its preoperatively calculated angle. | Device | VERION |
| Conventional, manual ink-marking for toric IOL alignmentAlso: Conventional, manual ink-markingSeveral manually performed methods are used to align the toric IOL at the intended axis. Most of them use a 3-step procedure. First, the horizontal axis of the eye is temporarily marked with ink in a seated position to correct for cyclotorsion when changing into supine position. Three spots on the conjunctiva, close to the edge of the cornea, are applied at 0°, 90° and 180°, which may be done by using a bubblemarker or gravity marker with a calibrated horizontal position. Next, the desired alignment axis for the toric IOL is marked intra-operatively. The last step is to rotate the implanted toric IOL until the IOL markings agree with the alignment marks. After surgery is performed, the ink marks will disappear within a few hours. | Procedure or surgery | Conventional, manual ink-marking |
Primary outcome
Average error (in degrees) in toric IOL-axis
Time frame: at week 13 (after the first surgery, if bilateral surgery was performed).
1 secondary outcome
Percentage of eyes with residual refractive cylinder ≤0.5D
Time frame: at week 13 (after the first surgery, if bilateral surgery was performed).
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 16 Mar 2016.
- Background: PubMed 18721707Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
- Results publication: PubMed 21782085Visser N, Berendschot TT, Bauer NJ, Jurich J, Kersting O, Nuijts RM. Accuracy of toric intraocular lens implantation in cataract and refractive surgery. J Cataract Refract Surg. 2011 Aug;37(8):1394-402. doi: 10.1016/j.jcrs.2011.02.024.
- Results publication: PubMed 22999600Visser N, Berendschot TT, Verbakel F, de Brabander J, Nuijts RM. Comparability and repeatability of corneal astigmatism measurements using different measurement technologies. J Cataract Refract Surg. 2012 Oct;38(10):1764-70. doi: 10.1016/j.jcrs.2012.05.036.
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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.
Rudy Nuijts, MD, PhD principal investigator
Maastricht University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VERION for toric IOL alignment and Conventional, manual ink-marking for toric IOL alignment in people with Astigmatism, run by Maastricht University Medical Center at 1 site in Netherlands.
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 8 inclusion and 10 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 16 Mar 2016. 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 Netherlands. 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?
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?
Average error (in degrees) in toric IOL-axis (time frame: at week 13 (after the first surgery, if bilateral surgery was performed).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370953, which also lists 3 linked publications.
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 16 Mar 2016.