The purpose of this pilot study is to compare the perception of straylight in patients with CE marked multifocal intraocular lenses, measured with 4 different straylight measuring devices..
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PRIMARY CLINICAL STUDY ENDPOINTS:
Pre- and postoperative stray light perception measured with the C-Quant
(standard and with modified tube), Rostock Glare Perimeter, Double Pass System
and a subject questionnaire.
Secondary outcome
Uncorrected and best corrected distance visual acuities (ETDRS 100% and 25%
charts) • Capsular bag striae ratings • IOL Decentration/Tilt • Posterior
capsule opacification (PCO) • Optical visual symptom incidence • Complication
rates • Adverse event rates • Subjective subject questionnaire
Background summary
This pilot study encompasses only commonly used CE approved and marketed
multifocal intraocular lens types, the Tecnis® ZMA00 and the newly marketed
Tecnis® ZMB00 (both manufactured by AMO Groningen BV) to compare the patients
perception of straylight. Acrylic IOLs were selected to ensure small incision
cataract surgery where the preoperative parameters of the corneal curvatures
and the topography remain manageable. The control lens ZMA00 is a multi-piece
IOL where the optic is produced of hydrophobic acrylic material and the haptic
is made of extruded PMMA. The ZMB00 is a single-piece IOL made of the same
hydrophobic acrylic material like the control lens. The optic design of all
multifocal lenses is 6.0 mm, the overall diameter is 13.0 mm. The posterior
edge geometry of all lenses is designed for inhibition of posterior capsular
opacification. The diffractive pattern which makes the lens a multifocal lens
is modified in the ZMB00 and is intended to cause a reduction in the amount of
scattered light.
It is known that bright light sources like the sun or headlights of a car in
the night are perceived as glare causing discomfort especially in critical
situations like bad weather conditions. This discomfort glare is described by
patients in combination with starbursts and/or halos or just scattered light
perception. The degree of discomfort produced by a bright light source can be
rated from acceptable to not acceptable and up to even threatening. The degree
of discomfort may also depend on the size of the glare source, the illumination
level as well as the projection area on the retina. These complaints are more
frequent in patients with multifocal intraocular lenses than in patients with
monofocal intraocular lenses. Recently AMO Groningen BV has introduced a new
design into a multifocal IOL (ZMB00). In the optical bench there was a
significant reduction of the amount of straylight. To test whether this
reduction is also observed with implanted IOLs is the aim of this study. Due to
their nature, the complaints of discomfort glare are difficult to quantify.
However, in recent years several measuring devices have become available. This
study is designed to compare the perception of straylight in patients with two
CE marked multifocal intraocular lenses as measured with a marketed medical
device called C-Quant (Oculus, CE marked, class I). In addition, a C-Quant is
modified having an extended tube (no CE mark). The straylight measuring device,
C-Quant with regular and extended tubes, used in this pilot study is the
outcome of more than 20 years of investigations with a variety of
straylightmeters and mesopic glare testers to ease the examination, especially
for the patients and to receive more reliable data on visual capabilities under
glare conditions. Using former devices, patients have had difficulties to
adjust to different light levels under glare conditions. The C-Quant uses the
forced choice method in which the patient has to watch a test field which is
split into a left and right half circle to allow simultaneous comparison of the
observed flicker strength. The patient has to choose the half circle which
flickers most. A special algorithm allows a 0 or 1 response (Yes or No). The
consistency of the responses gives information on the reliability of the
measurement outcomes. As the device is measuring forward scattering (what the
patient sees). A variety of optical tube lengths will be used to change the
visual angle of the glare source. Two other investigational devices without CE
mark (Rostock Glare Perimeter and Double Pass System) will be used for the
evaluation of straylight. These devices are not CE marked.
The Rostock Glare Perimeter is an investigational device consisting of a
central light source in a projection screen. This device was developed by Prof.
Dr. Rudolf Guthoff, University of Rostock. The light source induces scattering
pattern in the patient*s eyes. A beamer projects light dots in various
distances from the central light source. The patient have to focus on the
central light source and give responses on whether or not he/she is able to see
the peripheral light spot projections. The objective straylight measuring
device, the Double Pass System, used in this study is an investigational
device, developed by Prof. Dr. Pablo Artal, University of Murcia, Spain. The
Double Pass method has been used in vision research for more than 10 years,
mainly for measuring the point spread function on the retina. By increasing the
sensitivity of the device, the device is now able to quantitatively and
objectively measure the amount of straylight on the retina. It measures the
forward scattering of light in the eye.
Study objective
The purpose of this pilot study is to compare the perception of straylight in
patients with CE marked multifocal intraocular lenses, measured with 4
different straylight measuring devices..
Study design
This study is a single-center, bilateral intra-individual, randomized, double
blind pilot study.
Intervention
Implantation of two CE marked Multifocal Intra-ocular lenses after extraction
of the natural opacified lens.
Study burden and risks
Patients requiring cataract surgery with lens implantation usually have a
monofocal lens implanted. This makes the use of reading glasses necessary.
Multifocal intraocular lenses reduce the need for reading glasses but are only
obtainable for an additional fee which covers the extra costs of the multifocal
intraocular lens. In this study patients are offered the possibility to have
multifocal lenses implanted at no additional cost. As a part of the study
patients are asked to undergo additional eye measurements during two extra out
patient clinic visit. Multifocal lenses can give rise to additional straylight
which could result in complaints in some patients. Patients participating in
this study will have a small risk of perceiving addiional straylight. In the
most severe cases this could result in lens exchange with another type of
lensimplant. This would be an additional surgery with risks comparable to those
of cataract surgery. (It should also be mentioned that implantation of a
monofocal intraocular lens is no absolute garantuee that complaints of unwanted
light fenomena will not occur).
van Swietenlaan 5
9728 NX Groningen
NL
van Swietenlaan 5
9728 NX Groningen
NL
Listed location countries
Age
Inclusion criteria
1. Age 18 or greater
2. Bilateral cataracts for which phacoemulsification cataract extraction and posterior chamber IOL implantation have been planned.
3. Visual potential in each eye of 0.8 (20/25 Snellen) or better as determined by surgeon*s estimation
4. Normal corneal topography with preoperative corneal astigmatism of 1.5 D or less (or the ability to manage astigmatism to 1.0 or less postoperatively by incision placement)
5. Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
6. Signed informed consent
Exclusion criteria
1. Concurrent participation or participation during the last 30 days in any other clinical trial
2. Use of systemic or ocular medications that may affect vision (the use of any miotic agent is specifically contraindicated)
3. Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, diabetes, etc.)
4. Uncontrolled systemic or ocular disease
5. Irregular astigmatism
6. Requiring an intraocular lens <16.0 or >26.0 diopters
7. History of ocular trauma or prior ocular surgery
8. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies
9 10. Uncontrolled ocular hypertension or glaucomatous changes in the retina
11. Intraocular inflammation or recurrent ocular inflammatory condition
12. Known pathology that may potentially affect vision
13. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils)
14. Capsule or zonule abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, an eccentric anterior capsulorhexis, or posterior capsule defects
15. Retinal changes that may affect vision or that may require surgical intervention during the course of the study (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.)
16. Planned moving or moving to another home address during the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31644.042.10 |