Intacs is the trademark name for microthin prescription corneal implants designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus. Intacs corneal implants for keratoconus instructions for. Intacs inserts are small rings of synthetic material that are. This may result in blurry vision, double vision, nearsightedness, astigmatism, and light sensitivity. Keratoconus, we are participating in a formal study of the effect of combined intacs and cxl in patients with keratoconus or corneal ectasia after previous lasik or prk. Intacs is to be a logical addition to the stepwise treatment of keratoconus that improves visual acuity and, in a number of patients, has negated the need for corneal transplantation thus far. Intacs, or corneal inserts, received fda approval for treating keratoconus in august 2004. Intacs are intracorneal ring segments which are implanted into the cornea through a corneal tunnel created with a laser. Intacs intracorneal ring segments complications in. Request pdf on aug 1, 2003, bsb wachler and others published intacs for keratoconus vol 110, pg 1031, 2003 find, read and cite all the research you need on researchgate. Pdf postintacs fitting for a keratoconus patient researchgate.
Apr 03, 2020 intacs keratoconus pdf posted on april 3, 2020 by admin intacs for keratoconus treatment in new jersey and nyc. The purpose of this evaluation is to study the effects of implanting intacs inserts, identical to those commercially available to correct myopia, into the corneal stroma of patients with keratoconus mild to moderate and having a clear cornea. The principle of the procedure is to flatten the cornea deformed by keratoconus. Intacs prescription inserts for treatment of nearsightedness and astigmatism associated with keratoconus patient booklet humanitarian device.
But intacs surgery for the treatment of common myopia is considered an elective vision correction procedure. Intacs is the trademark name for microthin prescription inserts which were previously used as a form of refractive surgery in the treatment of low levels of myopia or nearsightedness, but have recently received fda approval for keratoconus. Prospective, nonrandomized selfcontrolled comparative trial. Intacs insertion is a procedure used to correct for small refractive errors like nearsightedness or astigmatism irregularly shaped cornea or for keratoconus coneshaped cornea. Keratoconus is a condition that causes the cornea to thin and bulge out like a cone over time. Intacs surgical eye implants for keratoconus webmd. Keratoconus intacs treatment canadian keratoconus foundation. This study is being conducted under fda guidelines. As with any refractive surgery, the procedure involves risks such as over or undercorrection and infection. Intacs is potentially a safe and efficacious treatment option in the management of advanced keratoconus. Intacs is the trademark name for microthin prescription inserts which were previously used as a form of refractive surgery in the treatment of low levels of myopia or nearsightedness, but has recently received fda approval for keratoconus. The procedure is usually performed in the ambulatory setting under local anesthesia by an ophthalmologist. Sixteen patients 20 eyes with keratoconus, 11 men 69% and 5 women 31%, with a mean age of 39.
In this procedure, small plastic semicircular rings are placed beneath the surface of the cornea which help smooth the shape of the cornea. The goal of the clinical trial is to study the benefits and safety of the combined intacs and cxl as well as to evaluate the. International journal of keratoconus and ectatic corneal diseases, septemberdecember 20. In 2004, intacs received approval in some situations for the treatment of keratoconus. Intacs keravision, fremont, calif are small arclike polymethylmethacrylate segments approved for the correction of low myopia in 1990. Intacs and other intrastromal corneal ring surgery for the correction of keratoconus usually are covered by major medical insurance. Intrastromal corneal ring segments intacs for keratoconus university health alliance uha will reimburse for intrastromal corneal ring segments when it is determined to be medically necessary and when it meets the medical criteria guidelines subject to limitations and. The product is designed with a fixed outer diameter and width. Recently, intrastromal corneal ring segments intacs. Keratoconus kc is a disorder of the eye which results in progressive thinning of the cornea.
Narayana nethralaya was the first hospital to introduce intacs in the country in 2005. It also causes distortion in vision with multiple images, streaking and sensitivity to light. Intacs corneal implants are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred. Intrastromal corneal ring segments intacs for keratoconus. Intacs corneal implants for keratoconus instructions for use for use. Originally fdaapproved in 1999 for the surgical treatment of mild myopia 1. Keratoconus 1 keratoconus this material will help you understand keratoconus, its causes, and how it may be treated. Learn more about intacs surgery 2925 lord baltimore drive, suite 300, baltimore, md 21244. The insertion of intacs in the cornea is considered to be a safe procedure, but there can be some side effects, including infection, pain or discomfort for up to 48 hours, glare and halos, and allergic reaction to anesthetic eye drops. Intacs inserts are placed into the corneal periphery through a small 1. A modified intacs procedure was performed on subjects with keratoconus. Intacs to help your vision keratoconus eye disorder. Federal law for use in the treatment of myopia and astigmatism.
Treatment of moderate to severe keratoconus with 6mm intacs sk. This procedure is quick, painless and performed in the comfort of dr. The intacs corneal implants treatment nomograms for keratoconus are based on the use of the 0. When the disease progresses, vision deteriorates and may not improve with spectacles. Their original application was for the refractive correction of mild myopia.
Ask your eye surgeon and health insurance provider for details. In order to reduce the myopia and the irregular astigmatism induced by keratoconus, two. In this series, intacs provided good results with respect to visual acuity, corneal topography, and mrse in eyes with advanced keratoconus without major complications or the need for segment explanation. Joseph colin in france first conceived of the concept of using intacs to treat patients with keratoconus and published his first report on the safety and efficacy for this indication in 2001. Keratoconus often starts when people are in their late teens to early 20s. Another new and exciting development which will make this procedure safer and more commonly acceptable is the use of the femtosecond laser to create the channels to insert the intacs, which has been described for the first time this year.
Use of intacs in patients with keratoconus is an effective and costeffective procedure. Intacs surgery for keratoconus kc inserts treatment. Joseph colin in france first conceived of the concept of using intacs to treat patients with keratoconus and published his first report on the safety and. These tiny plastic inserts are placed just under the eyes surface in the periphery of the cornea and help reshape the cornea for clearer vision. For example, a recent study conducted in china showed longterm stability of postlasik corneal ectasia after crosslinking without any relevant side effects. In this vein, the use of intacs intracorneal ring segments addition technology, lombard, ill. Pdf efficacy and safety of intacs sk in moderate to severe. The use of intacs as a therapeutic modality in contact lens intolerant patients with mild to moderate keratoconus is. This is a pdf file of an unedited manuscript that has been accepted for publication.
Intacs are two, arc like, pmma segments which were designed to be surgically inserted into the deep corneal stroma to flatten the central cornea. The goal of the clinical trial is to study the benefits and. Keratoconus is a degenerative corneal disease affecting vision that is characterized by generalized thinning and cone shaped protrusion of the central cornea, usually in both eyes. Keratoconus often affects both eyes, and can lead to very different vision between the two eyes. Intrasomal corneal ring segments intacs inserts are an alternative treatment strategy for patients with mild to moderate keratoconus who are no longer able to achieve adequate vision using contact lenses or glasses and for whom corneal transplant is the only remaining option. Pdf intacs addition technology, des plaines, il surgery has become a standard procedure in the treatment of keratoconus. Eight patients 10 eyes with keratoconus, 7 men 87% and 1 woman %, with a mean age of 38. Nov 08, 2012 keratoconus and ectasia have been successfully treated with both intacs and corneal collagen crosslinking. Intacs corneal rings can they treat your keratoconus. Intacs, corneal inserts for treatment of keratoconus and. Mar 28, 2014 intacs intacs is the trademark name for microthin implantable intracorneal ring inserts a procedure used to improve mild myopia, also studied to determine its usefulness in reducing hyperopia, astigmatism and helping improve vision for those with keratoconus. Recently, this surgical option has been approved for use in treating keratoconus.
Federal law for use in the treatment of nearsightedness and astigmatism associated with keratoconus. Intacs inserts for treating keratoconus oneyear results joseph colin, md,1 be. Preoperative examination included uncorrected visual acuity ucva, bestcorrected visual acuity bcva, manifest refraction, keratometric data, and corneal to. Here at the clei center for keratoconus, we are participating in a formal study of the effect of combined intacs and cxl in patients with keratoconus or corneal ectasia after previous lasik or prk. The intacs corneal implants treatment nomogram for keratoconus is based on the clinical results from implanting the 0. The intacs inserts are to be placed equidistant on each side of the incision.
Pachymetry was measured at the incision site, and the incision was made at 66% of the corneal thickness. Preoperative examination included uncorrected visual acuity ucva, best corrected visual acuity bcva, manifest refraction, keratometric data, and corneal to. In more severe cases a scarring or a circle may be seen within the cornea while the cause is unknown, it is believed to occur due to a combination of genetic. In this procedure, small plastic semicircular rings are placed beneath the surface of the cornea which help smooth the shape of. In some conditions, when no cure is available, sometimes simply preventing further progression can be enough to help the patient. Intacs are prescription corneal implants that were previously used as a form of refractive surgery for treating low level myopia and nearsightedness.
The cornea is the clear window in the front of the eye see picture on the right. They are an alternative to laser surgery, and are tiny, crescentshaped prescription devices made of plastic polymer. Intacs are two, arc like, pmma segments which were designed to be. Intacs inserts using the femtosecond laser compared to. To evaluate the use of intacs microthin prescription inserts kera vision, inc. Keratoconus and ectasia have been successfully treated with both intacs and corneal collagen crosslinking. The product configuration recommended for the treatment of keratoconus is one thinner intacs insert placed superiorly and one thicker intacs insert placed inferiorly, with temporal incision placelnent 9. For many keratoconus patients, intacs corneal inserts can be a safe, minimally invasive way to slow or halt that progression. Pdf to examine the safety and efficacy of intacs sk for moderate to severe keratoconus kc using femtosecond technology. Intacs for keratoconus full text view clinicaltrials.
By gently reshaping the cornea to improve vision without removing corneal tissue, the structural integrity of the eye is maintained. Addition technology inc, fremont, calif have been reported to improve the refractive defect in keratoconus 14 and in postlaserassisted in situ keratomileusis keratectasia. How is the intacs procedure for keratoconus performed. The vision symptoms slowly get worse over a period of about 10 to 20 years. At 1 year, all 10 patients he operated became contact lens tolerant and demonstrated an improvement in both uncorrected and bestcorrected acuity 4. Intacs inserts using the femtosecond laser compared to the. Sep 06, 2017 intacs inserts are a less invasive alternative to laser eye surgery for patients with mild myopia nearsightedness or the eye disease keratoconus. Coverage issues guidelines and medical technology assessment recommendations are developed to determine coverage for avmed s benefits, and are published to provide a better understanding of the basis upon which coverage decisions are made. Brian will place in peripheral layer of the cornea to help reshape the steep area of the cornea. Intacs are a tiny, clear, semicircle inserts that dr.
In 2003, intacs was given a fdaapproved designation for the treatment of keratoconus. Intacs intacs is the trademark name for microthin implantable intracorneal ring inserts a procedure used to improve mild myopia, also studied to determine its usefulness in reducing hyperopia, astigmatism and helping improve vision for those with keratoconus. Title eyes levinger keratoconus managed with intacs, arch ophthal, oct 05 53 uusitalo treating keratoconus with intacs, jrs may 05 50 alio one or two intacs for correction of keratoconus, jcrs may 05 26 colin current surgical options for keratoconus, jcrs feb 03 0 tunc intacs for. Intacs, corneal inserts for treatment of keratoconus and ectasia. Intacs for keratoconus vol 110, pg 1031, 2003 request pdf. The methods of treatment include early keratoconus can be managed by giving rigid. Intacs are thin plastic, semicircular rings inserted into the mid layer of the cornea. Intacs are thin plastic, semicircular rings, which are surgically inserted under the surface of the cornea. To evaluate the effect of intacs sk corneal ring segment implant for treatment of patients with moderate to severe keratoconus, who have clear central. Intacs can then be offered as an alternative to penetrating or lamellar keratoplasty for visual rehabilitation. An early symptom of keratoconus is a change in the spectacle power. The goal of intacs in keratoconus is to decrease the cone and make the corneal optical surface smoother. The effectiveness of this device for this use has not been demonstrated.