Stabileyes Capsular Tension Ring - Abbott Medical Optics Inc. (AMO)

Description

The Stabileyes™ Capsular Tension Ring (CTR) semi-circular ring is made entirely of Perspex® CQ UV(ultraviolet light absorbing polymethylmethacrylate, PMMA) with one manipulation eyelet at each end of the ring. The CTR is intended for placement into the equator of the capsular bag during cataract surgery by using either forceps or a specially designed insertion instrument. CTRs are available in tow sizes, Model STBL12US (12 mm diameter) and Model STBL13US (13 mm diameter).

Indications

CTRs are indicated for the stabilization of weakened, broken, or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.

Contraindications

CTRs should not be used in the presence of a torn or compromised capsular bag or significant, progressive pseudoexfoliation. CTRs should not be used in patients 12 years old or younger due to the developing eye.

Warnings

The long-term effects of progressive zonular stability following implantation of a CTR are not known.
Patients with pseudoexfoliation syndrome or an otherwise compromised zonule due to trauma exhibit a wide variety and degree of intraoperative and postoperative complications hat must be taken into consideration by the surgeon prior to using the CTR. All subjects with a compromised zonule may not be suitable to receive a CTR.
The medical literature has reported that eyes with pseudoexfoliation syndrome and a shallow (below average) anterior chamber depth may exhibit a greater tendency to develop zonular instability, intraoperative and postoperative complications.
The use of a CTR in patients less than 18 years of age may increase the risk of radial tears of the capsulorhexis as reported in the medical literature.
The safety of the CTR in cases of zonulolysis greater than 33% has not been established.

Precautions

The CTR is for single use only
This device may not be reused
This device may not be resterilized
Product is sterile and must remain in its original package until ready for use
Use sterile technique and remain in a sterile field when handling the product
Do not use after expiration date
Do not use if the package is opened or damaged
Inspect product prior to use. Do not use damaged products
Surgeons should be familiar with the CTR insertion technique prior to use
Store between 50 and 85 degrees F

StabilEyes™ Capsular Tension Ring

The StabilEyes™ CTR is proven to reduce cataract complications (both intraoperative and postoperative), reduce the rate of vitrectomy, reduce patient follow-up visits associated with vitrectomy, and reduce the risk of explanting decentered IOLs.

What is the StabilEyes™ Capsular Tension Ring?

StabilEyes™ is a safe and effective way to ensure capsular bag stability and promote IOL centration.

The StabilEyes™ Capsular Tension Ring is a compression-molded Perspex CQ PMMA ring, the same high-quality material as premium PMMA IOLs.
The StabilEyes™ Capsular Tension Ring has been approved in Europe since 1994 and over 100,000 capsular tension rings (CTRs) have been implanted.
The StabilEyes™ Capsular Tension Ring is an open, flexible ring design with eyelets at the open end of the ring to allow for rotation and manipulation in the bag.
StabilEyes™ is available in two sizes: 12 mm / 10 mm for small eyes and 13 mm / 11 mm for large eyes.

- Larger number is the ring diameter in uncompressed state (before insertion)
- Smaller number is the ring diameter in compressed state (after insertion)

StabilEyes™ is a system (ring + reusable inserter)
StabilEyes™ is injected into the capsular bag (via the syringe-style Micro Inserter or forceps) to maintain the integrity of the bag during complicated cataract surgery.
No CTR related complications reported in eight (8) years of European use. (Ophtec Data on File)

What does the StabilEyes™ Capsular Tension Ring do?

The StabilEyes™ Capsular Tension Ring enables you to safely ensure stability and promote centration when capsular bag stability is, or could be, compromised.

StabilEyes™ Capsular Tension Rings

Provide circular expansion of the capsular bag
Reduce luxation or decentration of the IOL
Stabilize the capsule in case of defective or absent zonulae
Stabilize the capsule in the case of high myopia
Provide safe IOL centration in eyes with zonular dehiscence
Stabilize the capsule during phacoemulsification surgery
Improve long-term IOL centration for multifunctional IOLs (multifocal, aspheric, etc.) after elective surgery

When centration is key, multifocal IOLs, aspheric IOLs and future high-tech IOL designs require excellent centration to deliver optimal optical performance. StabilEyes™ Capsular Tension Rings have proven to provide the centration needed to maximize optical performance.

Reference: 1. Ophtec Study Data: IOLs observed under slit lamp biomicroscopy.

Insertion

StabilEyes™ is a complete, easy-to-learn system consisting of a ring and a syringe-style Micro Inserter. Utilizing simple, familiar insertion instruments and processes, surgeons can expect the following from StabilEyes™:

Controlled ring delivery
Precise ring placement
Same procedure prior to, or following, phacoemulsification
Choice of forceps delivery

Using The Micro Inserter

StabilEyes™ instructions for use:

The Micro Inserter is a high-quality, specialized, stainless steel instrument designed to aid in the insertion of the StabilEyes™ Capsular Tension Ring into the lens capsule.
Although the capsular tension ring (CTR) can be inserted without the use of this Inserter, use of this instrument is highly recommended as it provides a much higher level of control during the procedure.
The Inserter consists of a hook-tipped wire (used to grasp the CTR) attached to the plunger and cylinder. The CTR is loaded into the cylinder tip and then inserted into the lens capsule.

Loading the StabilEyes™ Capsular Tension Ring into the inserter:

Using sterile techniques, open the primary packaging for the CTR onto a sterile field. Open the CTR case by applying pressure to the cap while rotating counterclockwise. After removing the cap, the CTR can be observed within the case. Locate the manipulation holes on each end of the CTR.
Depress the plunger on Inserter to expose the hook-tipped wire. Place the hook into either manipulation hole located on the CTR and then slowly release pressure on the plunger to draw the CTR into the Inserter. The hook-tipped wire should grasp the CTR and slide easily into the Inserter tip. When the plunger is completely released, the CTR is fully loaded and ready for insertion.

Inserting the StabilEyes™ Capsular Tension Ring:

With the CTR loaded into the Inserter, place the tip of the Inserter through the capsulorhexis, angling it toward the equator of the lens capsule.
Slowly depress the plunger of the Inserter while observing the instrument tip to ensure that the CTR exits the tip in the proper orientation.
After verifying that the CTR is exiting the Inserter tip correctly, continue inserting the CTR taking care that the distal tip of the CTR does not bind on or puncture the lens capsule.
When the plunger is fully depressed, gently remove the hook-tipped wire from the manipulation hole. The CTR should expand to fill the equator of the lens capsule.

FAQs

Question
When should a surgeon consider using the StabilEyes™ Capsular Tension Ring?

Answer
Surgeons should use the StabilEyes™ Capsular Tension Ring when there is a loss, or suspected loss, of stability in the zonular structures that may result in inadequate support for a posterior chamber IOL. Surgeons should also consider using the StabilEyes™ Capsular Tension Ring when postoperative shrinkage of the capsular bag is a concern or when high myopia or small pupil sizes contribute to increased risk of rupturing the capsular bag during surgery.

Question
Are capsular tension rings (CTRs) easy or difficult to implant?

Answer
Once surgeons learn when, and how, to implant the StabilEyes™ Capsular Tension Ring it is a very easy product to use. While there is a brief learning curve, any surgeon who can implant a posterior chamber IOL can implant a CTR. The Micro Inserter is a syringe-style system that provides for precise placement prior to or after lens removal. The eyelets on the open ends of the ring are designed for easy manipulation of the StabilEyes™ Capsular Tension Ring at any point during surgery.

Question
Is the use of CTRs important when implanting multifocal and other high-tech optic designs?

Answer
Yes, very much so. In particular, multifocal and aspheric lens designs are dependent upon excellent centration for optimal outcomes. CTRs minimize decentration from capsular bag shrinkage and weakened zonules helping to keep these highly sensitive IOLs centered and performing according to design.

Question
Do CTRs really work?

Answer
Yes. With almost 10 years of use in Europe, CTRs are the most anticipated product among U.S. surgeons in years. In a recent U.S. survey, eye surgeons, regardless of surgical volume, overwhelmingly indicated a preference for the use of CTRs upon approval by the FDA.

Question
Are there complications associated with CTRs?

Answer
Yes. Complications associated with CTRs are basically the same complications associated with the use of an IOL. These complications include retinal tears, rhematogenous retinal detachment, CME, direct retinal trauma from mobile IOLs and vitreous hemorrhage. In a European study1 of eye surgeons that use CTRs, the incidence of adverse events was only 0.07%.

Question
Can surgeons â€œplanâ€ to use the StabilEyes™ Capsular Tension Ring or is it usually a decision made during the procedure?

Answer
In a recent survey of U.S. cataract surgeons, it was indicated in about 44% of cases where a CTR is used that surgeons know preoperatively that zonules are compromised. This means that in over half of the procedures where StabilEyes™ is used surgeons make the decision during the procedure. This fact underscores the importance of ensuring that StabilEyes™ Capsular Tension Rings are available in the operating room for every case.

Question
When, during the case, can the CTR be inserted?

Answer
The StabilEyes™ Capsular Tension Ring can be inserted at any time following capsulorhexis and prior to IOL insertion to maintain or re-establish capsular integrity.

Question
Are CTRs safe with YAG procedures?

Answer
Yes. In a multi-site, multinational study,1 the StabilEyes™ Capsular Tension Ring was proven to be safe and effective with YAG posterior capsulotomies.

Question
Should the StabilEyes™ Capsular Tension Ring be available for all cataract cases?

Answer
Yes. Since capsular weakness is discovered intraoperatively in about 56% of cases,2 surgeons should have the StabilEyes™ Capsular Tension Ring available in the OR for all cases.

Question
How often will surgeons use StabilEyes™?

Answer
Based on initial surveys of U.S. surgeons,2 it is expected that CTR use may reach a level of five (5) percent of cases.

Question
Do surgeons receive reimbursement when using StabilEyes™?

Answer
Yes. Surgeons can bill for a complicated case code under Medicare when using StabilEyes™ and receive an additional reimbursement that averages approximately $170 in the United States. Surgeons currently bill for complicated cases in an estimated 2.8 percent of cataract procedures.

References: 1. Ophtec study on file. 2. AMO study on file.

Clinical Library

Description

Indications

Contraindications

Warnings

Precautions


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