The purpose of the study is to investigate the safety and effectiveness of the HF IF PIOL, and to compare performance with the Artiflex lens. Study outcomes will be used to obtain CE marking for the lens and for registration and marketing purposes.
ID
Source
Brief title
Condition
- Vision disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and effectiveness of the HF IF PIOL, by documenting:
• adverse event rates and best-corrected visual acuity (BCVA), 6 months
post-operative (safety);
• the improvement in uncorrected distance visual acuity (UDVA) at 6 months post
operative (efficacy);
• the predictability (attempted versus achieved) of the MSRE;
• the stability of spherical equivalent;
• the endothelial cell density decrease after stabilization of the surgically
induced cell loss (1to 6 months post-operative);
• subject satisfaction on resulting visual outcome.
In these, establishing the safety profile using adverse event rates and visual
acuity is considered the primary objective of the study. Additional objectives
are considered secondary.
Secondary outcome
The secondary objective is to compare the safety and effectiveness of the study
lens with the Artiflex Myopia PIOL. The outcome of the comparison will be used
to determine how the study lens performs compared to the Artiflex Myopia PIOL,
especially regarding occurrence of deposits and endothelial clearance, with a
comparable safety profile.
Background summary
Phakic intraocular lens (PIOL) implantation is a technique to correct
refractive errors. Since the development of the Artisan Aphakia and its first
use in cataract surgery in 1978, OPHTEC BV has introduced a range of
iris-fixated products, each recognizable by the unique *iris claw* fixation
principle on which the design is based. This fixation principle is extremely
versatile, and allows positioning of the lens in any meridian and centered on
the pupil. Once fixated, the lens does not rotate and remains at the same
position.
In 1986 the Artisan Phakic IOL for myopia with a biconcave optic was the first
PIOL to be introduced on the market by OPHTEC BV. Following the Feasibility
Study with the biconcave optic, the configuration of the original biconcave
lens was changed into a convex-concave design in 1991 to reduce potential
complications. The Multicenter Study that was set up as a result of the design
change demonstrated that the lens is safe, efficient, predictable and stable.
Introduction of the Artisan for hyperopia and Artisan PIOL for myopia with an
optic diameter of 6.0 mm followed in 1992 and 1997 respectively. The Artisan
Myopia lens was FDA approved in 2004. In 1999, the Multicenter Study with the
Toric Artisan PIOL for the correction of myopia and hyperopia in combination
with astigmatism was started. The results demonstrated that implantation of the
Toric Artisan PIOL is a safe, predictable and effective way to reduce ametropia
and astigmatism in a single procedure. The Toric Artisan was introduced to the
market in 2001.
Modern cataract surgery with phacoemulsification through a small *sutureless*
wound stimulated OPHTEC BV to develop a foldable PIOL. After demonstrating the
safety, efficacy, predictability and stability of the lens in a Multicenter
Study that started in 2003, the introduction of the foldable Iris-Fixated
Myopia Artiflex PIOL followed in 2005. Continuing on this path of development,
OPHTEC BV introduced a toric version of the PIOL, the Artiflex Toric in 2009.
In this lens, the possibility to correct astigmatism in one procedure and the
advantages of a foldable lens are combined. Despite the clinical success of the
Artiflex lenses, an aspect of improvement remains the occurrence of pigment and
non-pigment precipitates that form on the lens optic in a low percentage of
patients and which requires treatment with corticosteroids.
In its constant search for innovative products, OPHTEC BV now developed the
hydrophobic acrylic (HF) iris-fixated (IF) PIOL for the correction of myopia.
This lens combines advantages of the Artisan and Artiflex lenses.
Study objective
The purpose of the study is to investigate the safety and effectiveness of the
HF IF PIOL, and to compare performance with the Artiflex lens. Study outcomes
will be used to obtain CE marking for the lens and for registration and
marketing purposes.
Study design
The study is a prospective, single-blind, randomized, multicenter, comparative
clinical evaluation in low to highly myopic eyes. Estimated enrollment time is
3 months with a follow-up period of 6 months. For the main objective of
establishing safety and effectiveness of the HF IF PIOL, an uncontrolled study
design approach will be used. Following ISO 11979-7:2006 annex A, the number of
subjects to be enrolled in such a design is 125, to achieve a minimum of 100
evaluable patients. As all subjects also receive the Artiflex Myopia PIOL in
the non-study eye, safety and effectiveness of the HF IF PIOL will also be
compared with the Artiflex Myopia PIOL as a secondary objective.
Intervention
Subjects will receive the HF IF PIOL in one randomly assigned eye and the CE
certified Artiflex Myopia PIOL in the other eye. Surgical procedure and
medication regime are standard for phakic iris-fixated lens implantation.
Study burden and risks
Benefits of PIOL implantation are spectacle and contact lens independence, a
high level of comfort and high image quality. The clinical study may prove the
clinical safety and effectiveness of the HF IF PIOL and superiority over the
Artiflex PIOL. If the study results in CE marking of the lens, future patients
may benefit from the improved product (compared to existing iris-fixated
PIOLs). For study subjects, the primary benefit from implantation of the HF IF
PIOL may be improved distance vision and spectacle independence. Secondary
benefits compared to implantation of the Artiflex and Artisan PIOLs will be
assessed in the clinical trial as secondary objectives.
Risks are deemed identical to Artiflex implantation and are listed in the
instructions for use as complications. Risks were reduced to broadly acceptable
risk (BAR) or as low as reasonably possible (ALARP) level. Product safety and
performance are in accordance with specifications. Product design is in
accordance with its intended use. Residual risks to be evaluated in the
clinical trial are occurrence and severity of deposits on the PIOL (i.e. iris
pigment and non-pigment precipitates), and occurrence and severity of glare and
halos.
Most complications can be avoided by careful patient selection according to the
IFU. The severity of complications can be limited by early detection and
treatment. Compliance with the postoperative monitoring recommendations is
therefore crucial. If patient selection and postoperative monitoring are
performed as per protocol, benefits to the patient outweigh the risks of
participation to the clinical trial.
Schweitzerlaan 15
Groningen 9728NR
NL
Schweitzerlaan 15
Groningen 9728NR
NL
Listed location countries
Age
Inclusion criteria
• Age >18 years;
• Axial myopia that can be fully corrected with a PIOL within the power range of -2.0 to -14.5 D (i.e.: myopia ranging from approximately -1.5 to -15.5 D, depending on keratometry values);
• Anticipated subjective astigmatism not exceeding 1.5 D in both eyes;
• Stable refraction (±0.5 D; ±1.0 D for refractive errors>10.0 D), as expressed by manifest refraction spherical equivalent (MRSE) for >=12 months prior to surgery, verified by consecutive refractions and/or medical records or prescription history;
• CDVA >=0.5 in each eye;
• UDVA <= 0.5 in each eye;
• Difference between cycloplegic and manifest refractions < 0.75 D;
• Current contact lens wearer has a stable refraction (± 0.5 D) on 2 consecutive examination dates at least 7 days apart, and the lenses were not worn for at least 2 weeks for rigid and toric contact lenses, or 3 days for spherical soft contact lenses prior to the first refraction;
• Minimum ACD of 3.2 mm (from epithelium to anterior lens capsule) by biometry, resulting in a critical distance between PIOL and endothelium of 1.5 mm or more as simulated with anterior segment imaging;
• Age specific, minimum endothelial cell density as follows (According to ISO11979-10):;18 to 25 years of age 2800 cells/mm2;
26 to 30 years of age 2650 cells/mm2;
31 to 35 years of age 2400 cells/mm2;
36 to 45 years of age 2200 cells/mm2;
> 45 years of age 2000 cells/mm2
• Any subject who is expected to have residual postoperative cylindrical refractive error of up to 1.5 D has been given the opportunity to experience his/her best spectacle vision with anticipated spherical correction only, and is willing to proceed with the surgery;
• Availability, willingness and sufficient cognitive awareness and physical ability to comply with examination procedures throughout the entire duration of the study.
• No secondary surgical procedure planned during the course of the study (e.g. laser treatment to correct astigmatism).
Exclusion criteria
• Ocular condition that can predispose for future complications or interfere with the ability to evaluate the safety or effectiveness of the lens;
• Acute or chronic disease or illness that would increase the operative risk or confound the outcome(s) of the study;
• Use of systemic or ocular medications that can confound the outcome of the study or increase the risk to the subject;
• Concurrent participation or participation during the last 30 days in any other clinical trial;
• Prior intraocular or corneal surgery;
• Patient, when examined preoperatively, not expected to achieve a postoperative CDVA of 0.5 or better;
• Insufficient space for the intended implant (ACD measured from epithelium <3.2mm);
• Abnormal iris (e.g. bulging or volcano shaped iris, aniridia);
• Abnormal cornea (e.g., keratoconus, opaque cornea, recurrent erosion syndrome, scars, or other cornea pathologies);
• Abnormal pupil (e.g. nonreactive, fixed, photopic diameter <2.0 mm);
• Ectopic pupil (>2 mm displacement from geometric center of cornea);
• Pupil >7 mm under scotopic conditions;
• Ocular hypertension (>21 mm Hg)
• Less than the minimal endothelial cell density as listed under inclusion criteria;
• Coefficient of variation of endothelial cell area >=0.45 (in both eyes);
• Endothelial disease that may potentially affect the visual outcome;
• History of retinal detachment;
• Evidence of retinal vascular disease or history of hypercoagulability;
• Glaucomatous changes in the retina or visual field;
• Glaucoma or glaucoma suspect;
• Any form of cataract;
• Corticosteroid responder;
• Active intraocular inflammation or recurrent ocular inflammatory condition;
• Monocular vision;
• Amblyopia;
• Microphthalmos or macrophthalmos;
• Immuno-compromised by steroids and/or antimetabolites;
• Pregnant, lactating, or plans to become pregnant during the course of the study
• Condition associated with fluctuation of hormones that could lead to refractive changes;
• Diabetes mellitus;
• Mentally retarded;
• Aged under 18;
• Surgical difficulty at the time of surgery which might increase the potential for complications;
• Not able to meet the extensive postoperative evaluation requirements.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| Other | Nederlands Trial Register: NTR4425 |
| CCMO | NL46242.068.13 |