Astigmatism Clinical Trial
Official title:
VERION Versus Conventional, Manual Ink-marking in Toric IOL Implantation
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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