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Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis

Primary Purpose

Cataract Senile, Astigmatism

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye
Sponsored by
Frank Bochmann
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Senile focused on measuring Cataract, Astigmatism, Toric intraocular lens alignment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Eye Clinic, Cantonal Hospital of LucerneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention arm

Arm Description

Study with one single arm. All participants will receive two interventions that will be compared to each other.

Outcomes

Primary Outcome Measures

Deviation of laser marking
Deviation of laser marking in the cornea compared to intended position of the axis in degrees
Difference of laser marking
Difference of laser marking in the cornea compared to manual ink marking in degrees.

Secondary Outcome Measures

Reduction of astigmatism
Total of reduction of astigmatism in the postoperative refraction
Decentration of manual ink marking
Decentration of the ink marking (yes or no)
correction of IOL position
Number of necessary corrections of IOL-position

Full Information

First Posted
February 20, 2023
Last Updated
March 20, 2023
Sponsor
Frank Bochmann
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1. Study Identification

Unique Protocol Identification Number
NCT05750862
Brief Title
Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frank Bochmann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile, Astigmatism
Keywords
Cataract, Astigmatism, Toric intraocular lens alignment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Other
Arm Description
Study with one single arm. All participants will receive two interventions that will be compared to each other.
Intervention Type
Procedure
Intervention Name(s)
Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye
Other Intervention Name(s)
Autotmated, topopgraphy guided marking of the inteded axis of IOL-Implantation with the Catalys femtosecond laser
Intervention Description
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
Primary Outcome Measure Information:
Title
Deviation of laser marking
Description
Deviation of laser marking in the cornea compared to intended position of the axis in degrees
Time Frame
1 month
Title
Difference of laser marking
Description
Difference of laser marking in the cornea compared to manual ink marking in degrees.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Reduction of astigmatism
Description
Total of reduction of astigmatism in the postoperative refraction
Time Frame
1 month
Title
Decentration of manual ink marking
Description
Decentration of the ink marking (yes or no)
Time Frame
1 month
Title
correction of IOL position
Description
Number of necessary corrections of IOL-position
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Bochmann, MD
Phone
0041412053416
Email
frank.bochmann@luks.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Amstutz, MD
Phone
0041412053327
Email
christoph.amstutz@luks.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Bochmann, MD
Organizational Affiliation
Eye Clinic, Cantonal Hospital of Lucerne, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Clinic, Cantonal Hospital of Lucerne
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Bochmann, MD
Phone
0041412053416
Email
frank.bochmann@luks.ch
First Name & Middle Initial & Last Name & Degree
Christoph Amstutz, MD
Phone
0041422053327
Email
christoph.amstutz@luks.ch

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
it is not foreseen to make individual participant data available to the researchers

Learn more about this trial

Accuracy of Topography Guided Automatic Marking of the Intraocular Lens (IOL) -Axis

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