Ophthalmic Devices Panel - August 1-2, 2002
INTRAOCULAR AND CORNEAL IMPLANTS BRANCH
Donna R. Lochner - Chief
- At the January 2002 meeting, the Panel reviewed premarket application (PMA) P010059, the Morcher capsular tension ring, and recommended that the PMA was approvable pending additional analyses of the clinical data. The document remains under FDA review. The issues that the Panel discussed were related in a letter to the sponsor. Their response is pending.
- Optonol, Ltd., premarket notification (510(k)) K012852-Ex-Press Miniature Glaucoma Implant, Models R-30 and R-50
Cleared as Substantial Equivalent to a predicate device on March 26, 2002
This device is different from previously cleared shunts in that it is a stainless steel tube with a blunt needle shaped penetrating tip at one end and a flat, angled flange at the distal end. It functions similarly in shunting aqueous fluid from the anterior chamber into a conjunctival bleb and is intended to reduce intraocular pressure in patients with glaucoma where medical and conventional surgical treatments have failed.
DIAGNOSTIC AND SURGICAL DEVICES BRANCH
Everette T. Beers, Ph.D. - Chief
Three devices have been approved since the January, 2002 Panel Meeting:
- On April 11. 2002 we approved P010018, the Refractec ViewPoint CK® System for Hyperopia. This device was considered by the panel which recommended that it was approvable on November 30, 2001. It is indicated for the temporary reduction of spherical hyperopia in patients who have 0.75 diopters (D) to 3.25 D of cycloplegic spherical hyperopia…the official indication continues, but ends with: The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction.
- The other approval was on December 19, 2001 for the VISX Humanitarian Device Exemption (HDE) H000002 for Custom Contoured Ablation Pattern Method for the treatment of certain patients with symptomatic decentered ablations from previous laser surgery as viewed on the Zeiss Humphrey topography unit.
- A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but exempt from the effectiveness requirements of a PMA. An approved HDE authorizes marketing of a Humanitarian Use Device (HUD).
- The HUD is "intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals (per year) in the United States."
- Use of the device at each institution is overseen by the IRB of that institution; IRB may make decisions on a case-by-case basis.
- On May 17, 2002, PMA P970027/S002, Bausch & Lomb Technolas 217A excimer laser system for high myopia with astigmatism was approved. The device is indicated for the reduction or elimination of high myopia < -12 D mean refractive spherical equivalent (MRSE), where the sphere is >-7 D and < -10.99 D and the astigmatism is between 0.0
and -3.5 D.
VITREORETINAL AND EXTRAOCULAR DEVICES BRANCH
James F. Saviola, O.D., Chief
PREMARKET NOTIFICATION (510(k)) CLEARANCES
We recently cleared an application on May 9, 2002 for the ChromaGen Reading Aid Soft Contact Lens by Cantor & Silver Limited of England, K012132.
The indication includes correction of refractive ametropia. The lenses may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.
This lens had previously obtained a marketing clearance on October 20, 2000 as an optical aid for people with red-green color vision deficiencies, K994320.
- There was a clinical study conducted that supported the use of the lens as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error. The 510k Summary of Safety and Effectiveness provides a description of the clinical study
- The clinical study did not support the use of the ChromaGen lenses in treating dyslexia, or in improving the general reading speed. Dyslexia is a poorly defined anomaly with some controversy as to how it is identified. It is not clear if dyslexics or some subset of dyslexics have a visual deficit or what it may be.
- Current literature studies report inconsistent results concerning the effect of colored filters on reading rate and comprehension. Symptoms of "reading discomfort", along with rate of reading and reading comprehension can be strongly influenced by psychological factors.
- The lens was not cleared for the indication to treat dyslexia or improve reading speed. A precaution statement was added to the labeling to inform patients that results are variable due to the subjective nature of visual discomfort and, not all patients will experience success.
The predicate device is the previously cleared ChromaGenV2.0 lens. A new product code designation (NIC) was obtained to aid in tracking reports to FDA concerning contact lenses with the indication to aid reading discomfort. This does not mean that a new class of contact lenses was established by clearance of this device.
There is minimal risk associated with this device’s new indication to aid reading discomfort. The risk is comparable to other tinted soft contact lenses. While effectiveness is expected to be variable, the lens may be beneficial for some people.
The Paragon CRT lenses for overnight orthokeratology which were discussed at the January 2002 panel meeting were approved on June 13, 2002.
Paragon CRT™ (paflufocon B), Paragon CRT™ 100 (paflufocon D),
Paragon Quadra RG™ (paflufocon B), and Paragon Quadra RG™ 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy - P870024/S043
Following the panel meeting, ODE issued an approvable letter which the firm responded to. Following review of the additional clinical data provided and interactive review of the draft product labeling final approval was granted.
These lenses are manufactured by Paragon Vision Sciences of Mesa, Arizona and are indicated as follows:
The Paragon CRT™ (paflufocon B) and Paragon CRT™ 100 (paflufocon D) rigid gas permeable Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes. The lenses are indicated for overnight wear in a Corneal Refractive Therapy fitting program for the temporary reduction of myopia up to 6.00 diopters in eyes with astigmatism up to 1.75 diopters. The lenses may be disinfected using only a chemical disinfection system.
The Paragon Quadra RGä (paflufocon B) and Paragon Quadra RGä 100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy have essentially the same indication as the CRT lenses, however, the pretreatment myopia is up to 3.00 diopters in eyes with astigmatism up to 1.50 diopters.
Note: To maintain the Contact Lens Corneal Refractive Therapy effect of myopia reduction overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intended correction.
In order to address effectiveness concerns of the Quadra RG design used overnight, a further analysis of existing data was conducted by comparing the Quadra daily wear effectiveness data with the CRT overnight data at 3 months (the duration of the daily wear study). There were no statistically significant differences in reduction of pretreatment refractive error, accuracy and stability, or uncorrected visual acuity.
Among the many recommendations by the Advisory Panel was a limitation to those 18 years or older since limited data on this age group were presented at the January 2002 meeting. There was not an age restriction included in the final approval by FDA since the company provided additional data on adolescents between ages 12 to 17 who completed the study, which accounted for 11% of the completed dataset. The primary effectiveness concern in this age group is their expected progression of myopia. Although daily wear corneal reshaping (orthokeratology) has been practiced since the 1960’s, the long term safety effects of overnight contact lens wear for reshaping the cornea are not known for any age population.
- The Menicon Z™, an RGP lens was approved on July 12, 2002 in a supplement for extended wear up to 30 days, P990018/S2.
Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.
Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.
The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.
Although this was not discussed at a panel meeting, we did solicit homework assignments from three panel members in order to corroborate our internal FDA review. The panel reviews did not raise any additional clinical issues that were unique to this device or different from those identified in the internal review. All three panel members recommended approval of the device for extended wear up to 30 days.
The post approval condition of conducting a clinical study was placed upon this approval in the same manner for the two previously approved silicone-hydrogel lenses from Ciba.
PMA PRESENTATION - AUGUST 1, 2002
PMA P970043/S010 - ALCON LABORATORIES, INC.
Device: CustomCornea™ Myopic LASIK with the LADARVision™ 4000 System
Indication for Use: in Wavefront-Guided CustomCornea™ Laser In-Situ Keratomileusis (LASIK) correction for the reduction or elimination of myopia up to -7D with less than -0.5D of astigmatism at the spectacle plane in subjects who are 21 years of age or older.
Panel Recommendation by vote: Approvable with Conditions (unanimous 9-0)
Conditions of Approval
- Postoperative symptom and satisfaction data for conventional LADARVision LASIK eyes should be compared to wavefront guided LASIK eyes. The resulting comparison data should be included in the patient and physician labeling.
Additionally, the labeling in the Patient and Physician's Information Booklets should be revised as follows
The following statements should be included:
- Wavefront guided LASIK has demonstrated slightly superior optical quality (reduced monochromatic aberrations) compared with conventional LADARVision LASIK. Minor improvements were noted in visual acuity and contrast sensitivity relative to conventional LADARVision LASIK.
- The accuracy of the correction for myopia is still the primary determination of uncorrected image quality and vision.
- There is no data to support improved functional performance (activities of daily living such as reading, driving) or satisfaction rates in patients with wavefront guided LASIK as compared to the conventional LADARVision LASIK.
- There were only 4 eyes in the study above -6 D of refractive error.
- Conventional LADARVision LASIK evidenced an approximate 77% increase of higher order aberrations over preoperative levels, while wavefront guided LASIK showed an approximate increase of 20% higher order aberrations over preoperative levels.
- No retreatment data is available.
- The study population is primary Caucasian with no patients being over 65 years old. A demographic distribution table from the study should accompany the statement.
The following tables also should be included in both booklets
- Change in Best Spectacle Corrected Visual Acuity
- Change in Low Contrast Best Spectacle Corrected Visual Acuity
- Postoperative uncorrected visual acuity (UCVA) as compared to preoperative best spectacle corrected visual acuity (BSCVA) or a statement that only 50% of patients saw well without glasses postoperatively as compared to their best preoperative spectacle correction
- The entire data table of subjective symptoms as presented in the body of the clinical study should be in the labeling so as to include the following categories of response: significantly better, better, no change, worse, significantly worse.
The Exclusion category in the Physician's Information Booklet should include:
- patients with dry eye.
- preexisting dry eye and/or large nighttime pupils may decrease your satisfaction with the LASIK procedure and this issue should be discussed with your physician.
Statements in the Patient Information Booklet should be revised as follows:
- Postoperatively a patient's eyes should become stable after 1 month
- The Visual Acuity as presented in a chart showing 6 months postoperative values should be clarified as "Best Corrected Visual Acuity With Glasses or Contact Lenses."
GENERAL ISSUES DISCUSSION AUGUST 2, 2002
Purpose of the discussion: to obtain the Panel's recommendations for clinical studies for phakic intraocular lenses (IOLs) and for subsequent PMA data analyses. The topic had been discussed previously at a 1998 Panel meeting and the resulting documents, Refractive Implants: Guidance for Investigative Device Exemption (IDE) and Premarket Approval (PMA) Applications; Draft Guidance for FDA and Industry for issued for comment in August, 2000. At this panel discussion additional updated recommendations were sought for phakic IOLs.
Guest Speakers: Drs. Henry Edelhauser and Bernard McCarey from Emory University discussed the collection and analysis of endothelial cell density data. Dr. Liliana Werner from the Storm Eye Institute of the Medical University of South Carolina discussed the evaluation of lens opacities.
Panel discussed FDA questions related to the following clinical topics
- Endothelial Cell Density - study population/inclusion criteria; examination schedule; testing methodologies; study analyses; and sample size
- Evaluation of the Natural Lens for Cataractogenesis- what level of evaluation should be performed and when; specific recommendations for defining the term "clinically significant" lens opacities, the use of quantitative methods vs. the use of the more semi-quantitative grading system; duration of the study and the possibility of the use of post-approval studies
- Contrast Sensitivity Substudy - what would be considered clinically significant levels, the use of different evaluation methods; and recommended analyses of the data
Information on the status of the tentative November 14-15, 2002 meeting date will be available on the web in late September
Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail email@example.com
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