VERION Versus Conventional, Manual Ink-marking in Toric IOL Implantation

March 15, 2016 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. Best corrected distance visual acuity (BCVA)
  2. Uncorrected distance visual acuity (UCVA)
  3. Residual refractive astigmatism
  4. Wavefront aberrations
  5. Complication profile

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VERION
In this group the VERION-tools (Digital Marker) are used for the alignment of the toric IOL
Device: VERION for toric IOL alignment
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.
Other Names:
  • VERION Measurement Module and Digital Marker
Active Comparator: Conventional, manual ink-marking
In the group the conventional manual marking is used for the alignment of the toric IOL
Procedure: Conventional, manual ink-marking for toric IOL alignment
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.
Other Names:
  • Conventional, manual ink-marking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average error (in degrees) in toric IOL-axis
Time Frame: at week 13 (after the first surgery, if bilateral surgery was performed).
at week 13 (after the first surgery, if bilateral surgery was performed).

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of eyes with residual refractive cylinder ≤0.5D
Time Frame: at week 13 (after the first surgery, if bilateral surgery was performed).
at week 13 (after the first surgery, if bilateral surgery was performed).

Other Outcome Measures

Outcome Measure
Time Frame
Best corrected distance visual acuity (BCVA)
Time Frame: at week 13 (after the first surgery, if bilateral surgery was performed).
at week 13 (after the first surgery, if bilateral surgery was performed).
Uncorrected distance visual acuity (UCVA)
Time Frame: at week 13 (after the first surgery, if bilateral surgery was performed).
at week 13 (after the first surgery, if bilateral surgery was performed).
Residual refractive astigmatism
Time Frame: at week 13 (after the first surgery, if bilateral surgery was performed).
at week 13 (after the first surgery, if bilateral surgery was performed).
Complication profile
Time Frame: at week 13 (after the first surgery, if bilateral surgery was performed).
at week 13 (after the first surgery, if bilateral surgery was performed).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Rudy Nuijts, MD, PhD, Maastricht University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL51895.068.14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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