Cataract SenileNCT05750862
Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis
A study testing Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye in people with Cataract Senile and Astigmatism, run by Frank Bochmann at 1 site in Switzerland.
Trial summary
In cataract surgery, the opaque lens is replaced by an artificial intraocular lens. The procedure also allows for correction of an refractive error such as myopia, hyperopia or astigmatism. In case of correction of an astigmatism, the axis intraocular lens has to be alligned to the axis of the corneal astigmatism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract Senile, Astigmatism
- What is being tested?
- Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Mar 2023to 1 Jan 2025
- 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 scheduled for cataract surgery who opt for a femtolaser-assisted cataract surgery (FLACS) and Implantation of a toric intraocular lens. (both are extra options not covered by the insurance)
- Corneal astigmatism more than 1.o diopters confirmed in a measurement of corneal topography (Pentacam and Cassini topography devices)
Who cannot join
- Earlier corneal or intraocular refractive interventions (C-TEN, Lasik…)
- Irregular corneal astigmatism
- Corneal pathologies associated with ectasia and/or irregular astigmatism (Pterygium, Keratoconus, pellucide marginal degeneration…)
- Earlier intraocular or ocular surface involving surgeries
- Severe dry eye disease
- Contraindication of performing cataract surgery under topical anaesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis in Toric IOL-impantation in Femtosecond Laser Assisted Cataract Surgery (FLACS). A Prospective Non-randomised Controlled Study
In cataract surgery, the opaque lens is replaced by an artificial intraocular lens. The procedure also allows for correction of an refractive error such as myopia, hyperopia or astigmatism. In case of correction of an astigmatism, the axis intraocular lens has to be alligned to the axis of the corneal astigmatism. There are serveral options, the intendet position of the axis can be marked on the cornea, either manually using ink and a special caliper or with an automatic laser device.
The aim of this study is to assess the accuracy of topography guided automatic marking of the intended IOL-axis in toric IOL-implantation in femtosecond laser assisted cataract surgery (FLACS)
Read the detailed description
In cataract surgery, the opaque lens is replaced by an artificial intraocular lens. Based on a preoperative measurement of the eye (biometry) the power of the artificial lens is calculated so that refractive errors may be corrected. If high corneal astigmatism is present a correction of this astigmatism is also possible and offered to the patients. This may lead to a certain degree of spectacle independence. The astigmatism is corrected by the implantation of a special toric lens (spherical and cylindrical correction). This toric lens has to be positioned in the eye so that the axis of the IOL-cylinder aligns 90° to the axis of the corneal cylinder. The axis of the corneal cylinder has to be measured and marked before the intervention. Usually, the intended axis of placement for the toric IOL is marked with ink at the slitlamp or with the aid of a manual axis instrument. Anatomical landmarks without preoperative marking are also used. A clinical trends survey of the European society of cataract and refractive surgery (ESCRS) for 2021 has revealed that in 15% of all cataract cases (totally 550'000 cases assessed) a special toric IOL was implanted to correct a clinically significant astigmatism. About 75% use manual marking with ink. Only 25% of cases were operated using a digital image registration.
The manual marking using a marking device is currently the gold standard. However, the manual marking might be not very precise. The thick ink-marks on the cornea and the limbus are not very well visible. Sometimes the marks are not perfectly centred on the optical axis of the eye. Head tilt and rotation of the eyeball if patients are not fixating may lead to a deviation up to several degrees.
One possible solution of this problem are digital imaging technologies. The Cassini topography instrument for example provides additional to the measurement of the axis and the cylindrical power of the cornea a digital image of the iris. If the cataract surgery is performed assisted by a femtosecond laser (FLACS), this digital image is transferred to the femtosecond laser. Based on this image the software of the laser is capable to determine the correct position of the axis of the cylinder of the cornea and the femtosecond laser can make two intrastromal marks in the cornea. These marks allow the surgeon to align the toric IOL without any preoperative manipulations with ink and marking tools.
The aim of this study is to assess the accuracy of topography guided automatic marking of the intended IOL-axis in toric IOL-implantation in femtosecond laser assisted cataract surgery (FLACS)
- Conditions
- Cataract Senile, Astigmatism
- Being tested
- Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye
- Keywords
- Cataract, Astigmatism, Toric intraocular lens alignment
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eyeProcedure or surgery
Also called Autotmated, topopgraphy guided marking of the inteded axis of IOL-Implantation with the Catalys femtosecond laser
The marking of the intended implantation axis of the interocular lens will be marked in all patients with topography guided in the corneal stroma with laser and in addition manually with a caliper and ink on the corneal surface
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | Study with one single arm. All participants will receive two interventions that will be compared to each other. Receives: Procedure: Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation of laser marking
Deviation of laser marking in the cornea compared to intended position of the axis in degrees
Measured: 1 month
Difference of laser marking
Difference of laser marking in the cornea compared to manual ink marking in degrees.
Measured: 1 month
Secondary outcomes (3)
Reduction of astigmatism
Total of reduction of astigmatism in the postoperative refraction
Measured: 1 month
Decentration of manual ink marking
Decentration of the ink marking (yes or no)
Measured: 1 month
correction of IOL position
Number of necessary corrections of IOL-position
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start20 Mar 2023
- Primary completion30 Sep 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Bochmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank Bochmann, Luzerner Kantonsspital
- Investigators
- Frank Bochmann, MD, Principal investigator, Eye Clinic, Cantonal Hospital of Lucerne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750862
- Sponsor's protocol ID
- 2023_D0001
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is not foreseen to make individual participant data available to the researchers
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis in Toric IOL-impantation in Femtosecond Laser Assisted Cataract Surgery (FLACS). A Prospective Non-randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05750862
- Acronym / sponsor ID
- 2023_D0001
- Conditions
- Cataract Senile, Astigmatism
- Keywords
- Cataract, Astigmatism, Toric intraocular lens alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Frank BochmannUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 2 Mar 2023 (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.
In cataract surgery, the opaque lens is replaced by an artificial intraocular lens. The procedure also allows for correction of an refractive error such as myopia, hyperopia or astigmatism. In case of correction of an astigmatism, the axis intraocular lens has to be alligned to the axis of the corneal astigmatism. There are serveral options, the intendet position of the axis can be marked on the cornea, either manually using ink and a special caliper or with an automatic laser device.
The aim of this study is to assess the accuracy of topography guided automatic marking of the intended IOL-axis in toric IOL-implantation in femtosecond laser assisted cataract surgery (FLACS)
Detailed description
In cataract surgery, the opaque lens is replaced by an artificial intraocular lens. Based on a preoperative measurement of the eye (biometry) the power of the artificial lens is calculated so that refractive errors may be corrected. If high corneal astigmatism is present a correction of this astigmatism is also possible and offered to the patients. This may lead to a certain degree of spectacle independence. The astigmatism is corrected by the implantation of a special toric lens (spherical and cylindrical correction). This toric lens has to be positioned in the eye so that the axis of the IOL-cylinder aligns 90° to the axis of the corneal cylinder. The axis of the corneal cylinder has to be measured and marked before the intervention. Usually, the intended axis of placement for the toric IOL is marked with ink at the slitlamp or with the aid of a manual axis instrument. Anatomical landmarks without preoperative marking are also used. A clinical trends survey of the European society of cataract and refractive surgery (ESCRS) for 2021 has revealed that in 15% of all cataract cases (totally 550'000 cases assessed) a special toric IOL was implanted to correct a clinically significant astigmatism. About 75% use manual marking with ink. Only 25% of cases were operated using a digital image registration.
The manual marking using a marking device is currently the gold standard. However, the manual marking might be not very precise. The thick ink-marks on the cornea and the limbus are not very well visible. Sometimes the marks are not perfectly centred on the optical axis of the eye. Head tilt and rotation of the eyeball if patients are not fixating may lead to a deviation up to several degrees.
One possible solution of this problem are digital imaging technologies. The Cassini topography instrument for example provides additional to the measurement of the axis and the cylindrical power of the cornea a digital image of the iris. If the cataract surgery is performed assisted by a femtosecond laser (FLACS), this digital image is transferred to the femtosecond laser. Based on this image the software of the laser is capable to determine the correct position of the axis of the cylinder of the cornea and the femtosecond laser can make two intrastromal marks in the cornea. These marks allow the surgeon to align the toric IOL without any preoperative manipulations with ink and marking tools.
The aim of this study is to assess the accuracy of topography guided automatic marking of the intended IOL-axis in toric IOL-implantation in femtosecond laser assisted cataract surgery (FLACS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Procedure: Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eyeStudy with one single arm. All participants will receive two interventions that will be compared to each other. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for cataract surgery who opt for a femtolaser-assisted cataract surgery (FLACS) and Implantation of a toric intraocular lens. (both are extra options not covered by the insurance)
- Corneal astigmatism more than 1.o diopters confirmed in a measurement of corneal topography (Pentacam and Cassini topography devices)
Key exclusion criteria (6 listed)
- Earlier corneal or intraocular refractive interventions (C-TEN, Lasik…)
- Irregular corneal astigmatism
- Corneal pathologies associated with ectasia and/or irregular astigmatism (Pterygium, Keratoconus, pellucide marginal degeneration…)
- Earlier intraocular or ocular surface involving surgeries
- Severe dry eye 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 |
|---|---|---|
| Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eyeAlso: Autotmated, topopgraphy guided marking of the inteded axis of IOL-Implantation with the Catalys femtosecond laserThe marking of the intended implantation axis of the interocular lens will be marked in all patients with topography guided in the corneal stroma with laser and in addition manually with a caliper and ink on the corneal surface | Procedure or surgery | Intervention arm |
Primary outcome
Deviation of laser marking
Time frame: 1 month
Deviation of laser marking in the cornea compared to intended position of the axis in degrees
Difference of laser marking
Time frame: 1 month
Difference of laser marking in the cornea compared to manual ink marking in degrees.
3 secondary outcomes
Reduction of astigmatism
Time frame: 1 month
Decentration of manual ink marking
Time frame: 1 month
correction of IOL position
Time frame: 1 month
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 6 Aug 2026.
- Individual participant dataSharing planned: No. it is not foreseen to make individual participant data available to the researchers
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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.
Frank Bochmann, MD principal investigator
Eye Clinic, Cantonal Hospital of Lucerne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye in people with Cataract Senile and Astigmatism, run by Frank Bochmann at 1 site in Switzerland.
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 6 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 6 Aug 2026. 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 Switzerland. 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?
Deviation of laser marking (time frame: 1 month). The study lists 2 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 6 Aug 2026.