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

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370953
• Other study ID #: NL51895.068.14
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: March 15, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: November 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

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.

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View Citation

Visser 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. — View Citation

Visser 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.2012.05.03 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best corrected distance visual acuity (BCVA)		at week 13 (after the first surgery, if bilateral surgery was performed).	No
Other	Uncorrected distance visual acuity (UCVA)		at week 13 (after the first surgery, if bilateral surgery was performed).	No
Other	Residual refractive astigmatism		at week 13 (after the first surgery, if bilateral surgery was performed).	No
Other	Complication profile		at week 13 (after the first surgery, if bilateral surgery was performed).	No
Primary	Average error (in degrees) in toric IOL-axis		at week 13 (after the first surgery, if bilateral surgery was performed).	No
Secondary	Percentage of eyes with residual refractive cylinder =0.5D		at week 13 (after the first surgery, if bilateral surgery was performed).	No