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

NCT05750862 | Unknown

• 1 other identifier: 2023_D0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Cataract Senile; Astigmatism

Keywords

Cataract; Astigmatism; Toric intraocular lens alignment

Outcome Measures

Primary Outcomes (2)

• Deviation of laser marking

  Deviation of laser marking in the cornea compared to intended position of the axis in degrees

  1 month

• Difference of laser marking

  Difference of laser marking in the cornea compared to manual ink marking in degrees.

  1 month

Secondary Outcomes (3)

• Reduction of astigmatism

  1 month

• Decentration of manual ink marking

  1 month

• correction of IOL position

  1 month

Study Arms (1)

Intervention arm

OTHER

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

Procedure: Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye

Interventions

Marking of the intended axis of IOL-Implantation manually with an ink and marking device on the surface of the eye PROCEDURE

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

Also known as: Autotmated, topopgraphy guided marking of the inteded axis of IOL-Implantation with the Catalys femtosecond laser

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank Bochmann: lead

Study Sites (1)

Eye Clinic, Cantonal Hospital of Lucerne

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Astigmatism; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Study Officials

• Frank Bochmann, MD

  Eye Clinic, Cantonal Hospital of Lucerne, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: March 20, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 1, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)