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Ophthalmic Devices Panel Advisory Committee Meeting Summary for January 17 - 18, 2002

BRANCH UPDATES

INTRAOCULAR AND CORNEAL IMPLANTS BRANCH
Donna R. Lochner - Chief

Ms. Lochner announced the temporary reassignment of Ms. Ashley Boam, branch biomedical engineer, to the Office of Planning and Legislation in the Office of the Commissioner in FDA. Ms. Boam will continue her responsibilities representing FDA on the ophthalmic standards committees, most importantly, the phakic intraocular lens (IOL) standard committees.

PMA PRESENTATION FOR JANUARY 17, 2002

PMA P010059 - MORCHER GmbH

Morcher Capsular Tension Ring (CTR)

Indication for Use: for the stabilization of the capsular bag

Panel Recommendation by vote:
approvable with conditions (8 for, 1 against, 1 abstention)

Conditions of Approval

1.The indications for use statement should be revised as follows:

  • For the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in patients aged 18 years or older.

2. Provide line data on the following:

  • Adverse event complications of Core Phase I and Core Phase II patients to include glaucoma, uveitis, cystoid macular edema, retinal detachment, branch retinal vein occlusion, phthisis, broken eyelets, and device explantation
  • Visual acuities of 20/40 or better preoperatively
  • Visual acuities of worse than 20/40 postoperatively
  • Information on the intraoperative estimate of amount of intact zonules
  • Evaluation of lens centration on postoperative dilated eye examination including the percentage of cases already examined with dilation

3. The labeling should be revised as follows:

  1. Addition of a physician information booklet that should include
    • The available ring sizes, with the justification for choosing either one
    • Data and information on the manual and "shooter" insertion and removal techniques
    • Outcomes analysis of clinical study
    • Positive indications for pseudoexfoliation, 1° zonular weakness (Marfan's Syndrome), 2° zonular weakness (trauma), prior vitrectomy
  1. Line data summaries from # 2 above.
  2. A statement that the endocapsular ring does not alter the progression of zonular instability over time
  3. Specific information on the degree of zonular damage treated in the study
  4. Cautionary statement regarding the use of the device in an eye with large areas of zonular damage
  5. Remove the following contraindications in the labeling:
    • Progressive eye disease
    • Glaucoma
    • Chronic Uveitis
    • Non-proliferative diabetic retinopathy
    • Progressive eye disease
    • Operative complications such as prolapsed vitreous or bleeding

4. Provide patient device implantation card to patient receiving the device

 

PMA PRESENTATION FOR JANUARY 18, 2002

PMA P870024/S043 - Paragon Vision Sciences

Paragon CRT™, CRT™100, Quadra RG, and Quadra RG100
rigid gas permeable contact lenses for overnight orthokeratology

Indications for Use: for the temporary reduction of naturally occurring myopia from -0.5 to -6.00 diopters of sphere with up to 1.75 diopters of astigmatism in an overnight wear fitting program

Panel Recommendation by Vote:

Paragon CRT lenses - Approvable with conditions, (11-0)
Paragon Quadra lenses - Approvable with conditions, 10 for - 1 against

Conditions of Approval - CRT lenses

  1. Revise indications to include "in ages 18 years and older"
  2. Revise labeling to include
    • Information noting that the study population was mostly Caucasian
    • A statement that the discontinuation rate of use was 34.6% with the reasons for discontinuation included
    • Statement that no data is known on those excluded from the study
    • Include data on patients who are post treatment uncorrected visual acuity (UCVA) targeted for emmetropia, stratified by mean refractive spherical equivalent (MRSE)
    • Include statement that orthokeratology does not affect the magnitude of pretreatment astigmatism
    • Include data on the post lens removal decrease in treatment affect with time stratified by refractive error
    • List transient changes in post treatment best corrected visual acuity (BSCVA)
    • Emphasize that lenses need to be worn each night overnight. Failure to do so can affect activities of daily living, e.g., night driving, visual fluctuations, changes in intended correction. Some wearers may need corrective lenses during the day.
    • State that 10-15% of the study patients did not achieve 20/40 UCVA with the trend worsening for higher myopic patients
    • Caution Statement that corneal edema is more prevalent with the use of the lens in high altitudes
    • Inclusion of refraction data on the time from removal of the lens to recovery to baseline visual acuity and MRSE, stratified by preoperative MRSE
    • Side effect data to include discomfort rates, punctate epithelial keratopathy, and other clinical findings.
    • Alternative therapies delineated in the patient information booklet, e.g., spectacles, contact lenses, refractive surgery alternatives
    • Statement on satisfaction rates
    • Transmissibility data showing the Dk/L values of the two contact lens materials to be placed in the physicians information
    • Physician and patient informational materials should be clarified for the target audience.
  1. Physician certification or training should be required prior to the use of the lens

Conditions of Approval - Quadra lenses

Same as numbers 1, 2, and 3 above
  1. The sponsor should submit further analysis of existing data to address effectiveness concerns

CLOSING ANNOUNCEMENT

Information on the status of the tentative March 14-15, 2002 meeting date will be available on the web within the next two weeks.

Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov

TRANSCRIPTS MAY BE PURCHASED FROM: (Written Request Only)
Miller Reporting Company, Inc.
507 C Street, N.E.
Washington, D.C. 20002
(202) 546-6666
or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

EXECUTIVE SUMMARY MAY BE PURCHASED FROM:
(Written Request Only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

CDRH Advisory Committee Database